Quality Assurance Director Resume Samples

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T Hane

Telly

Hane

15528 Adriel Parkway

New York

+1 (555) 560 3268

15528 Adriel Parkway

New York

Phone

p +1 (555) 560 3268

Experience Experience

New York, NY

Quality Assurance Director

New York, NY

O'Conner, Homenick and Green

New York, NY

Quality Assurance Director

Performing end-to-end testing life cycle governance for QA and assisting Project Managers and India leadership in planning and executing Book Of Work (BOW)
Oversees training and development of partners directly and indirectly managed and makes effective staffing decisions
Assist account managers/client partner in related business development activities to grow mindshare and market share in the account
Collects, analyzes, and manages real-time performance improvement data
Leads quality system Management Reviews and serves as Quality Management Representative at various venues
Works independently to manage the whole program and respective stakeholders/ and projects
Get first-hand customer information and uses it for improvements in services provided by Cognizant

Philadelphia, PA

Director of Quality Assurance

Philadelphia, PA

Hegmann-Bernier

Philadelphia, PA

Director of Quality Assurance

Responsible for all aspects of regulatory compliance including FDA and DEA regulations
Responsible for responses to client audit and regulatory observations
Implement and monitor the Quality Management System (QMS)
Develop and implement site specific quality assurance policies and procedures
Conduct internal, client, vendor, and regulatory audits
Manage the QA department
Has authority for all personnel actions

present

San Francisco, CA

Senior Director of Quality Assurance

San Francisco, CA

Smitham LLC

present

San Francisco, CA

Senior Director of Quality Assurance

present

You'll collaborate with Development, Implementation, and Operations teams to establish quality throughout the organization
You will prioritize, handle, and execute multiple tasks, define problems, and resolve issues with limited supervision from senior management
Tracking information about customer complaints to provide design, development and operations teams with product quality information
Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives
Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations
Oversee qualification, performance tracking, and reviews of contract manufacturers and laboratories and manage internal and external audits
You'll be responsible for the hands-on, daily management of 8-10 direct report staff workload

Education Education

Bachelor’s Degree in Computer Science

West Virginia University

Bachelor’s Degree in Computer Science

Skills Skills

Capable of performing the functions and be knowledgeable of aviation ground safety and management
Directs and oversees the work of quality professionals supporting manufacturing and design assurance
Strong communication skills to be able to communicate at all levels
Ability to manage others
Develops and implements quality strategy and objectives
Develops and implements quality planning, inspection methods and defect prevention/corrective action processes for new and existing products
Good analytical skills in order to aid in trouble shooting and problem solving
Legal ability to travel internationally
History of interacting with suppliers and sub-contractors in a production environment for the purpose quality control
Good leadership skills in influencing across job families

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Quality Assurance Director Resume Examples & Samples

Managing across multiple QA teams and a COE
Managing executive stakeholder relationship and cross LOB engagements
Utilizing a suite of testing tools that includes Quality Center, Quick Test Pro, etc
Performing end-to-end testing life cycle governance for cross-LOB QA andassistingProject Managers and offshore leadership in planning and executing Book Of Work (BOW)
Managing resource capacity and demand in sync with BOW
Providing coaching and mentoring to less experienced team members
Researching and evaluating alternative solutions to QA methodologyand making recommendations
Developing efficiencies and ways to improve testing processes
10 years of software testing experience
Demonstrated expertise using automated testing tools including Quality Center, Quick Test Pro, etc
Demonstrated proactive approach to problem solving
Good leadership skills in influencing across job families
High level of responsibility and ownership from inception through to implementation
Good analytical skills in order to aid in trouble shooting and problem solving

Aml Quality Assurance Director Resume Examples & Samples

Professional experience in an Anti-Money Laundering group at a large financial institution
Be degree educated or equivalent (with outstanding academic credentials)
ACAMS certified or an equivalent qualification
Experience in resolution of surveillance items flagged as potentially suspicious
The ability to critically review closure rationale to determine if the resolution was appropriate and appropriately documented
The ability to identify solutions for recurring issues identified during the QA process
Excellent time management skills and ability to execute tasks within tight deadlines
Excellent analytical, oral and written communication skills
Have excellent interpersonal skills necessary to work effectively with colleagues across regions and business units
The ability to research and resolve issues independently while working across teams to acquire information
Self-motivation and will be a team player

Director of Quality Assurance Resume Examples & Samples

10+ years of relevant industry experience; 5+ years of Managerial-related experience in the Pharmaceutical Industry
Extensive knowledge of quality management techniques and systems
GMP experience in an FDA related environment, inclusive of 21 CFR Part 11 compliance criteria
Highly organized

Director of Quality Assurance Resume Examples & Samples

RN, BSN
5+ years of supervisory experience
Success in obtaining NCQA accreditation

Director of Quality Assurance Resume Examples & Samples

Bachelor’s or master’s degree in accounting, finance, business administration, or equivalent
7+ years of experience in internal audit, assurance advisory, public accounting (financial services or banking or capital markets industry experience is preferred)
Internal audit, assurance, or accounting professional certification (CIA, CPA, CISA or equivalent) required
Experience in internal audit, assurance advisory, or public accounting quality assurance review function desired, but not required
Knowledge and appreciation of regulatory, accounting, and financial industry guidance and best practices relevant to the business, including technology implications
Knowledge and experience in control theory and professional audit practices required, including the assessment of inherent risk, evaluation of control design, development and execution of audit tests and the assessment of control deficiencies
Knowledge of the Institute of Internal Auditors International Professional Practices Framework (IPPF) and understanding of other regulatory standards for the internal audit professional
Proficiency in Microsoft Office and experience in use of automated audit/assurance documentation systems
Assist VP in development and execution of the department’s quality assurance program
Oversee the tracking, monitoring, and end-to-end management of corrective action plans associated with QA reviews
Support internal and external assessments of the internal audit function, including facilitating pre-planning and readiness reviews
Identify improvement opportunities and best practices based on results of quality assurance reviews
Partner with audit methodology and professional development team to design and deliver audit-related training program components to diverse groups of auditors with varying levels of experience based on QA results
Manage external benchmarking activities and maintain awareness of current, best-in-class internal audit practices

Director of Quality Assurance Resume Examples & Samples

7+ years of experience in Internal Audit, Assurance advisory, and/or Public Accounting
College Degree or Advanced Degree in Accounting, Finance, Business administration and/or related field
Internal Audit, Assurance, or Accounting professional certification (CIA, CPA, CISA or equivalent)
Knowledge and appreciation of Regulatory, Accounting, and Financial industry guidance and best practices relevant to the business, including technology implications
Knowledge and experience in control theory and professional audit practices required including the assessment of inherent risk, evaluation of control design, development and execution of audit tests and the assessment of control deficiencies
Knowledge of the Institute of Internal Auditors Professional Practices Framework and understanding of other regulatory standards for the internal audit professional
Financial services and Banking/Capital Markets industry experience
Experience in Internal Audit, assurance advisory, or public accounting quality assurance review function

Director, Audit Quality Assurance Resume Examples & Samples

Delivery of services in accordance with the Department's policies and procedures
Partnering with the Department's business, product and technology audit teams as needed
Establish and maintain ongoing relationships with headquarters, business and functional leadership for the subject areas
Create, manage and maintain a high performing team of domain experts and provide effective coaching and team member development for both in-house and co-sourced resources
Certified Internal Auditor (CIA), Certified Information Systems Auditor (CISA), Certified Public Accountant (CPA) or related certification preferred
Bachelor's degree and 12 years of relevant experience or High School/GED and 16 years relevant experience
MBA or equivalent preferred
Deep understanding of internal audit best practices, IIA standards, relevant regulatory requirements for the subject areas and past experience working with regulatory bodies (e.g., Fed, OCC, etc.)
Strong knowledge of business line processes, risks and controls for Commercial Lending and Leasing including Structured Finance and Corporate Finance
Fluent (speak, read and write) in English and local language
Must be willing to 30% of the time
Must apply via COS (internals) or through www.gecareers.com (externals) to be considered for this position
Candidates must have effective negotiation skills, a proactive and straightforward approach in communicating issues and strength in sustaining independent views
Previous experience working with local external regulators and risk and control thought leaders
Strong understanding of internal audit industry leading practices within the subject areas and the ability to apply them within the GEC organization
Ability to challenge internal audit professionals and influence positive change within internal audit
Ability to build strong trusting relationships with senior business stakeholders
Ability to suggest and implement policy changes to key internal audit stakeholders that will improve the overall quality program
Proven ability to direct personnel across multiple locations and operations and work in a matrix-type organization; proven ability to lead teams
Possess strong project management skills, make sound decisions, and exhibit initiative and intuitive thinking. Consulted often by others for advice and opinions and recognized as a leadership role model; and,
Strong oral and written communication, presentation and facilitation skills
Experience conducting Treasury and Risk related reviews

Quality Assurance Director, Risk Resume Examples & Samples

Partner with the IA Risk team, particularly with the Risk Chief Auditor and their direct reports
Reports to the Chief Auditor Strategy & Quality Assurance to carry out independent QA reviews of assurance work performed by internal auditors including Hot Reviews, Site Reviews, moderating cold review scorecards and Thematic Reviews
Assisting in the review and improvement of global IA methodology and practices through
Drafting and presenting methodology documents, guidance notes and practice guides
Developing and rolling out methodology training that are subject matter relevant to Risk and to take into account of current industry practice
Providing day to day support and guidance to the Risk IA team on methodology-related matters
Share industry knowledge, best practice, near misses experience from previous auditing background, transfer knowledge to Risk auditors via report review, QA Forum, hot reviews, lunch & learn sessions and bite-size training
Perform risk based Hot Reviews during live audits. Subject matter check and challenge, methodology adherence and understand auditors’ rationale and application of auditor judgment
QA of IA Risk’s completed risk assessment, Quarterly Refresh as part of Quarterly Business Monitoring again using industry knowledge
QA of IA Risk’s presentations for Regulators, Audit Committees, Risk Committees and other management committee reporting
Conduct Site Reviews (IA sites around the world to test IA standards and compliance with Group and local policies) using the QA testing strategy, i.e., develop and maintain the audit universe, risk assessment; incorporating scorecard results, thematic review results
Lead QA Thematic Reviews
Working with the QA team to develop a methodology to provide a valued interactive program of support and assurance to subsidiary boards and audit committees, as appropriate, on issues, trends, root causes and impacts to the respective business activities and the group
Working with the QA team to develop a methodology to provide a valued interactive program of support and assurance to senior management on issues, trends, root causes and impacts to the respective business activities and the group
Working with the QA team to develop a methodology to provide a valued interactive program of support and assurance in accordance with requirements and appropriate expectations to regulators and supervisors on issues, trends, root causes and impacts relating to governance, risk management and internal control issues
Working with the QA team to develop a valued interactive program of support and assurance covering the assessment and reporting of key risks across businesses and products, legal entities and jurisdictions, providing stakeholders with insight and practical solutions to improve the control culture and environment across Citigroup
Use QA scorecards for compliance with IA Methodology to identify root cause, trends, and impact on IA’s adherence to regulation in the respective jurisdictions in which Citi and IA operate
Participate in Risk IA team meetings and share best practice, common pitfalls identified from Scorecards, Site Reviews and Thematic Reviews
Develop an approach to promote knowledge sharing and promulgation of best practices across IA and Citi
Developing innovative and creative ideas which promote medium and long term improvement in audit practices, QA and IA operations (including finance, human resources, communications and infrastructure support)
Build relationships with Citi’s regulators
Candidates should have 15 plus years of diversified risk management experience, ideally including experience in audit or a related field. Experience of working in a global organization is desirable
Must have first-hand audit experience of risk management in a top tier investment bank covering at least one of the following disciplines in detail: credit, market, model and operational risk management. Knowledge and competency of one or more these disciplines is desirable
Have in-depth knowledge and practical experience of the adoption of best practice risk and compliance strategies as embodied in Basel and other international best practice in one or more Core Regulatory College countries (i.e., US, UK, Singapore, Hong Kong, Japan and/or Mexico)
Experience in working with international operations and teams. He/She should have a thorough knowledge of operations and control systems as well as an understanding of best-in-class audit methodologies. H/She must be proficient in risk and control analysis and audit concepts for a full range of products and specialized areas and will be skilled at analyzing root causes of problems and anticipating ‘horizon’ issues. Related certifications

Director of Quality Assurance Resume Examples & Samples

12+ years of Risk Management Audit experience
Previous experience with Credit, Market, Model and/or Operational Risk Management
Solid Internal Controls background

Associate Quality Assurance Director Resume Examples & Samples

30% Product Quality Strategy and CMC: Responsibility for Product Quality Strategy and ensuring appropriate Quality Representation on CMC meetings
30% Regulatory Submissions: responsibility includes ensuring appropriate quality review of regulatory submissions (i.e. filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the strategy set, and verifying regulatory submissions for accuracy/data integrity
20% Due Diligence and Integration: Provide both strategic and tactical quality input into New Product integration, New platform implementation and New acquisition for the assigned Business unit
10% Tactical Product Quality/ Compliance Governance: Maintain oversight for Business unit product performance and as needed
Facilitate other Quality related activities in collaboration with their CMC teams
Ensure appropriate escalation to Senior Management of significant quality or regulatory issues that may impact patient safety, product quality, supply or regulatory compliance
10% Leadership
PhD degree in Chemistry/Biology, or relevant scientific/engineering discipline with 7-10 years of industry experience; or MS or Bachelor’s degree with at least 10 years industry experience

Manufacturing & Quality Assurance Director Resume Examples & Samples

Establish and implement quality assurance procedures for TOMS globally
Create and execute processes to monitor TOMS’ production quality. Early detection of quality issues is a priority of these processes
Analyze data (for example: from production reject rate and from customer service returns) to quantify QA/QC issues
Analyze data to define and clarify product quality problems. Subsequently, create and execute solutions
“ Troubleshoot” QA/QC problems—identify the root cause of a production QA/QC problem and implement a solution
Support TOMS product development, especially with regards to product launches and product upgrades—create and implement test procedures to mitigate risk of product failure and maintain TOMS’ high quality and fit/comfort standards
Manage TOMS’ fit and wear testing programs
Advanced experience preferably in development, commercialization, manufacture of footwear, apparel, or accessories with leading multinational companies
Relevant experience in lean manufacturing, Six Sigma, or similar discipline would be an advantage
Leadership and ability to achieve aggressive company goals and highest standards in the agreed timelines
Undisputed integrity, personal, and business ethics; ability to build trust and respect with different stakeholder groups
Ability to work in a lean, fast-paced/changing environment, highly collaborative, multi-national teams, and must be comfortable with and embrace consensus decision-making
Bachelor’s degree in business or engineering
Master’s degree preferred in business or engineering
In line of education, 10-15 years of QA / QC experience in the footwear industry is required
Accessory and apparel experience is a plus
Fluent in oral and written English
P roficient with computer skills i.e. Microsoft Office, SAP, etc

Director Global Brand Quality Assurance Resume Examples & Samples

Build and sustain a QA to Brand and Brand to QA partnering relationship. Learn and understand the Brand's mission, values and consumer requirements and in collaboration with the Brand build the quality design and execution into the Brand. Establish the method and means to track performance and develop objective goals
Actively participate in the C2M process (concept/design, development, 1st production and distribution phases of product launches via "Right First Time" stage gate meetings or Brand specific commercialization processes to ensure a successful launch. Work closely with the QALT, GBSC, GSR, Product Development and R&D to ensure that appropriate product quality requirements are established and implemented
Lead the communication of quality problem notification/resolution to the Brand and vice versa. Actively pursue timely response and final preventive resolution to quality issues working with the QALT and functional partners. Active participant/co leads GCC monthly meetings
Participate in product line reviews and standards management. Participate in the supplier performance tracking program (GQMS) and in the supplier excellence program. Share "best practices" resolutions globally across brands and regions as a key part of the fragrance category lead responsibly
Active member of the QALT, participate in staff/brand lead meetings, contribute to the global QA strategy/objectives
BS/MS in science or engineering (chemistry, pharmacy, or food technology preferred) or equivalent through experience and additional training. Additional formal training in Quality Management a plus
Minimum 8 years experience in managerial positions, preferable in Quality Assurance, in consumer goods (cosmetics, packaged goods, food or pharmaceuticals)
Experienced in the use of quality tools with a sound statistical base: Quality Management systems, process mapping, tooling qualification, FMEA and others. Knowledge of packaging manufacturing processes is a plus
Computer literate with good working knowledge of Microsoft products. (SAP knowledge an added advantage)
Demonstrated success in handling multiple cross-functional projects
Demonstrated communication, leadership and human relations skills - able to work well with all elements within and outside of the organization

Healthcare Quality Assurance Director Resume Examples & Samples

Three or more years of Healthcare experience, preferably with Medicaid, including managed care organization experience
At least three years managing QA & Corrective Action programs
At least two years’ experience analyzing performance metrics & conducting trend analysis
Three or more years’ experience developing and implementing a Testing Strategy and Test Plan for large scale development projects, preferably in a healthcare environment
Demonstrated ability to communicate effectively, orally and in writing, with all levels of management
At least five years managing business QA functions
At least five years managing corrective action programs
Quality auditor certification, such as ISO 9001, NQA-1 or ASQ
Knowledge and experience with IEEE standards related to testing
Three or more years in the QA function of a large-scale claims processing organization
Six sigma is preferred
This is a REMOTE role, but should be in close proximity to our West Sacramento office as some on site work will be required periodically

Quality Assurance Director Resume Examples & Samples

Establishes annual Quality goals and objectives
Manages QA department resources so that business objectives are cooperatively supported without sacrificing product quality principles
Develops the quality department budget and capital budget
Execute the business plan within budget and look for opportunities to improve the efficiency of the group
Oversees the development, management and communication of quality metrics, trends or root cause analysis that will contribute to improvements minimizing or eliminating re-occurrence
Review and approve as necessary batch records, documentation for use in manufacturing, packaging, testing and disposition of products
Develop and maintain the Quality System Manual in compliance with requirements of FDA and internal QA index (GMP’s) requirements/guidelines
Serves as the primary site contact for Regulatory visits such as FDA. Responds to inspectional observations and any enforcement activities required
Provides regulatory and compliance expertise and interpretation to personnel in situations requiring such expertise
Oversee the GMP audit program and make recommendations for corrective actions to maintain compliance with federal and state agencies
Works with contract manufacturers/packagers to resolve quality issues
Elevate any major issues to Factory Manager and QA Corporate (VP QA and Corporate QA Director)
Directs document control for all OTC functions, manufacturing documentation and SOPs, GMP training, and reports to FDA and other federal and state agencies
Works closely with NPD (New Product Development), PCD (Product Concept Development), TPD (Technical Packaging Development) and R&D teams to put QA into Design (FMEA)
Takes an active role in qualification of OPI’s contracted manufacturers
Oversees package compatibility and stability testing and approval
Maintains a clear understanding and working knowledge of GMP requirements, Safety requirements, and SOP’s
Adheres to and enforces those policies within the team
Additional tasks, duties and/or responsibilities as assigned by management
Bachelor’s degree in Life Sciences discipline or other technical degree (i.e. Business, Chemistry, Biology, or Engineer etc.)
5+ years of managerial experience in Quality in the manufacture of Cosmetics, Skin care or related products
Progressive career history in the development and implementation of quality systems with oversight of QA, QC, validation, product release, CAPA and problem solving
Strong working knowledge of GMPs and/or FDA/ISO guidelines for manufacturing of Cosmetic and related products
Strong analytical and organizational skills with the ability to identify issues and generate solutions
Proficient in Microsoft Office (Word, Excel, Access and Outlook) and the ability to use an ERP warehouse management system
Ability to drive change and develop talent
Well developed decision making skills and results oriented
Ability to be flexible, multi-task, have strong organizational, communication and leadership skills to meet strict deadlines and manage multiple projects simultaneously in a fast paced environment

Quality Assurance Director Resume Examples & Samples

Develops Healthcare QA program implementation plans & procedures across Business Operations
Establishes and manages Corrective Action Program implementation
Directs staff day-to-day QA implementation activities
Manages scheduling, coordination & execution of QA related activities
Conducts QA audits of development, testing, design changes, implementation & operations
Conducts QA reviews to verify compliance with contract requirements & standards
Oversees all phases & iterations of risk management, testing & defect resolution
Serve as liaison with state officials coordinating quality audits & reviews as necessary
Interprets quality requirements & standards
Oversees continuous improvement implementation Required Skills · Three or more years of Healthcare experience, preferably with Medicaid · Bachelor’s degree · At least three years managing QA & Corrective Action programs · At least two years’ experience analyzing performance metrics & conducting trend analysis · Demonstrated ability to communicate effectively, orally and in writing, with all levels of management Preferred Skills · At least five years managing business QA functions · At least five years managing corrective action programs · Quality auditor certification, such as ISO 9001, NQA-1 or ASQ · Three or more years in the QA function of a large-scale claims processing organization · Two or more years in call center operations managed to meet inbound and outbound call level · Six sigma is preferred

Quality Assurance Director Resume Examples & Samples

Supports the implementation of Company programs, procedures, methods and practices to promote Starbucks key messages and achieve a competitive advantage
Assures compliance to quality and product safety standards from source of supply to consumer
Develops an integrated quality assurance program and budget covering beverage, food, merchandise, product distribution channels and retail facilities
Manages quality assurance projects and supervises partners
Progressive experience managing a research and development or quality assurance department
Motivation skills
Ability to apply sound business principles and practices to project management and change management processes

Quality Assurance Director Resume Examples & Samples

Lead and Manage India QA teams in alignment to global QA goals
Responsible for resource planning, allocation, evolving efficiency and maturity of India teams both at GSC and Vendor ODCs to deliver across various LOB Book of Work commitments
Accountable for optimal utilization of Test Automation Service, partnering with Automation Lead and LoB aligned CQOs on automation business cases and ROIs
Performing end-to-end testing life cycle governance for QA and assisting Project Managers and India leadership in planning and executing Book Of Work (BOW)
Researching and evaluating alternative solutions to traditional QA methodology and making recommendations
Developing efficiencies and ways to improve testing processes and quality across the SDLC
Represent India QA capability at CCB CQO and India CIO tables
(8-10+) years of Senior Level Management experience, providing Leadership to drive improved methodologies ensuring low cost, high quality support methodologies to deliver quality across the lifecycle
Experience with the development of successful quality control procedures and QA programs
10+ years of hands on software testing experience
Deep experience of setting up and management of large QA capability, pref for Consumer Banks
Detailed understanding of relevant technologies, various development lifecycles and quality assurance phases
5+ years recent experience managing teams within a Shared Service and/or Center of Excellence Model
Solid understanding of systems analysis, programming and operations

Director of Quality Assurance & Change Management Resume Examples & Samples

Responsible for development and application of control frameworks around (1) routine financial deliverables, (2) ad-hoc financial deliverables, and (3) change management around new or changed business activities
Ensure accounting and reporting controls are properly designed, including ownership around process maps and control documentation, and are operating as designed
Review, investigate, and assess errors and inconsistencies in financial documents and reports to assess whether control breakdowns have occurred
Development of metrics and meaningful reporting to senior management around control framework compliance
Create culture to propel meaningful process changes or improvements to increase efficiency, maintain credibility, and to continue to meet needs in an ever-changing business and regulatory environment
Lead the department's talent related practices including performance management, training and development, personnel changes and related items
Evaluate current control practices and policies and drives continuous improvement
Four-year college degree with an emphasis or major in Accounting, Finance or related field of study or equivalent work experience
10+ years of professional experience with progressive levels of responsibility in the financial service industry. Significant experience with auditing, SOX, and financial reporting is essential
Prior supervisory/managerial experience
Experience executing financial reporting and accounting control frameworks
Experience working directly with executives
Advanced analytical skills
Proven track record of building relationships in a 360 manner to gain influence across an organization,
Proven track record of building relationships to gain influence across an organization
Manage a team of contractors and/or staff

Director, Global Quality Assurance Resume Examples & Samples

Lead the overall management of the global Quality audit program, including: internal EL manufacturing and distribution sites, 3rd party, and supplier audits
Lead and manage a staff of 6 internal quality auditors who conduct audits and oversee audits/reports conducted by outside auditing agencies
Ensure that audits are conducted according to EL policy, that every audit has a timely audit report issued, and that corrective action/preventative action (CAPA) plans are identified for every audit
Implement and maintain databases for: audit scores, non-conformances and repeat non-conformances, such that continuous improvement can be objectively driven towards higher performance
Administer auditor training and calibration programs for consistency and standardization of audit practices
Implement, maintain and share a Community of Practice database for global application of best practice CAPA solutions derived from audit experience
In addition to managing the global Quality audit program, also personally conduct quality audits per the corporate audit schedule
Assure that existing and new corporate EL policies/procedures are integrated into quality audit inspections to ensure global compliance
Maintain a regulatory agency inspection nonconformance database
Be knowledgeable in and stay current in regulations pertaining to the personal care industry; e.g. OTC GMPs, dietary supplement GMPs, food GMPs, EU GMPs, etc. Act as an expert resource regarding regulatory GMP questions globally
Manage and administer the QA OTC complaint handling response investigation process according to policy/procedure and ensure that complaints are handled efficiently and timely

Claims Quality Assurance Director Resume Examples & Samples

Notify underwriters and team leaders of highly significant losses and/or claims
Coordinate the claims servicing of all accounts in accordance with client and carrier claim handling expectations and professional standards
Gather and review loss information and prepare claim summaries and exhibits for periodic claim review meetings with TPA, program team and industry associations, if applicable
Coordinate and conduct semi-annual claim review meetings with TPA and program team
Review and analyze client/program loss information to determine loss trends and other claims-related or loss control issues
Provide analysis, interpretation and recommendations to the underwriting team and management regarding individual client loss information and/or the overall program
Identify loss leaders in the program and work with underwriting to develop action plan to change results
Review and analyze coverage and exposure questions from the TPA
Monitor the performance of carriers/TPAs, acting as liaison between carriers/TPAs and underwriting, addressing service issues and documenting service issues to senior management as appropriate. This includes timeliness of claims handling, monitoring of reserves and verifying data integrity
Develop and grow relationships with insureds, brokers, carriers and TPAs

Director of Quality Assurance Resume Examples & Samples

Responsible for all aspects of regulatory compliance including FDA and DEA regulations
Implement and monitor the Quality Management System (QMS)
Develop and implement site specific quality assurance policies and procedures
Manage the QA department
Has authority for all personnel actions
Direct and coordinate activities of all QA operations to maximize quality, customer satisfaction, regulatory compliance, project timelines, productivity, and profitability
Member of the QMT, with responsibility for assigning and monitoring all CAPA activities
Demonstrate expertise with variety concepts, practices, and procedures
May provide consultation on complex projects and is considered to be the top level contributor/specialist
Typically reports to senior management
Responsible for employee career development and retention
Has annual and capital budget responsibility
Knowledge of analytical chemistry, demonstrated through
BA/BS in Chemistry, Biology or related scientific degree
7-15 years of related industry experience in an analytical laboratory
Organization, communication and analytical skills
Ability to understand and effectively communicate technical and business information, both oral and written to others, including co-workers, supervisors, subordinates, clients, and vendors
Intermediate mathematical skills, including: algebraic functions, statistics (mean, median, standard deviation, variance, probability), basic geometry (area, volume calculations), and scientific calculators

Quality Assurance Director Resume Examples & Samples

Oversee a strong global quality team by hiring and developing strong quality managers, establishing and actively managing performance expectations, and providing training opportunities to staff
Coach, motivate, and communicate to a mix of RUO (ISO 9001), CE-IVD (13485), and GMP (21CFR820) Quality Assurance teams (sites) across the globe
Develop and communicate a Quality vision and strategic objectives that aligns with the operations and business strategy
Set network wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality Management System
Oversee global Quality Control team performance to meet standard turnaround times, QC test first pass yield (test/retest error), OOS actions, and labor efficiency
Manage a complex global matrix organization to ensure the delivery of key CSD projects to customers and regulators (i.e. IronMan, Cascade)
Ensure global training is effective and that the plants operate within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective
Ensure effective management of quality objectives across multiple sites across the globe in within the Regulated Manufacturing Network of the Life Sciences Solutions Group
Set clear roles and responsibilities across the network with pro-active management controls
Actively coach technical professionals to achieve maximum performance
Ensure effective management of the network / site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance, process validation, internal auditing, R&D transfers, and manufacturing area support
Provide global quality system leadership to assure internal policies, customer expectations and regulatory requirements are met
Leads quality system Management Reviews and serves as Quality Management Representative at various venues

Quality Assurance Director Resume Examples & Samples

Oversees companywide adherence to our procedural documentation (quality management system) and its compliance with ISO 9001
Identifies and implements Quality Department goals and objectives in support of company-wide strategic business plans
Responsible for ensuring compliance to contracts, the elements of ISO 9001 and EMS policies/procedures throughout GATR
Serves as the primary interface with DCMA Quality Assurance Representative to encourage effective communication and good customer relations. Promotes and maintains good relations with the DCMA. Addresses mutual issues and concerns through teamwork with GATR employees and customer representatives
Supports the management of budgets and staffing forecasts to facilitate successful execution of the department goals and support of all projects company wide
Serves as primary Quality interface and coordinator for engineering and program management issues and manufacturing activities, including production control, procurement, planning, assembly, test and ship
Manages the required training, process improvement activities, and the development and implementation of new systems affecting the Quality Department
Facilitates the efforts to implement industry-wide/best practice standards
Implements a rigorous continuous process improvement program with emphasis on Lean, cycle time reduction, elimination of rework/defects, and root cause analysis
Maintains Quality metrics, and a management dashboard of those metrics, and assesses performance against project and enterprise goals
Implements and optimizes the use of tools in support of the quality processes and procedures
Coordinates with all GATR facilities (and Cubic facilities as appropriate) to converge on common tools, common processes and common data/reports/metrics
Represents the Quality organization, as necessary, during Physical Configuration Audits, Material Review Boards, Configuration Control Boards, Corrective Action Boards, Manufacturing reviews and customer meetings
Manages the day-to-day operation of all quality functions: inspection, MRB, supplier management, Quality Engineering, corrective/preventive actions, etc

Senior Director, GLP Quality Assurance Resume Examples & Samples

Work with the QA management to define the strategy for quality management in WuXi AppTec Co., Ltd. GLP Laboratories including process reengineering or continuous process improvement and quality training
Support the development and implementation of a WuXi AppTec Co., Ltd. GLP-wide quality system and Quality Management System (QMS)
Participate in the expansion of GLP principles and international laboratory quality standards (e.g. ISO) to other laboratory areas in WuXi AppTec Co., Ltd. as requested
Participate in communication with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management
Review and approve QA regulatory documents when required
Conduct and report QA activites in support of BU regualtory activities, i.e., study inspections/audits, vendor audits, and facility inspections
Assure regulatory authority inspections are fully supported
Provide input to GLP QA Suzhou SOPs, and BU Operational SOPs
Ensure consistent inspection practices of GLP QA operations within China
Assume the responsiblities and role of VP GLP QA when delegated
Monitor local projects so that work is on course to meet regulatory or client submission dates
Oversee local QA work prioritization and resource management
Provide local QA groups with general direction and guidance
Degree in Natural Sciences or Medicine or related experience
At least 15 years experience in medical or preclinical Research & Development
Understanding of Quality systems and global regulatory (GLP) requirements
Excellent interpersonal and leadership skills
Excellent communication, both written and oral, in English and Mandarin

Director, Clinical Quality Assurance Resume Examples & Samples

Leads the development/enhancement, implementation and maintenance of the CQA Quality Management System and oversees associated activities
Responsible for oversight and leadership of CAPA program and quality risk management to enable timely identification and communication of compliance issues/risks, including trend analysis and quality metrics review to foster optimized compliance and continuous process improvement
Develops and presents periodic reports describing quality/compliance metrics/trends and identifying areas of potential risk to senior management
Provides GCP compliance consultation to clinical teams and other stakeholders on process enhancement/compliance and quality issue management, ensuring consistent quality standards and fostering strong working relationships
Leads vendor quality oversight activities and serves on any assigned operational and/or governance committees
Oversees administration of SOPs/WPs which facilitate execution of both in-house and outsourced clinical trials/programs compliant with ICH/GCP standards
Ensures GCP/SOP/Inspection Readiness training programs are maintained and provided as appropriate to all global staff supporting clinical trials
Provides oversight for GCP, SOP, and WP training compliance for staff within CQA Training Administration remit

Director of Quality Assurance Resume Examples & Samples

Serves as the leading technical expert in the area of quality assurance engineering for the company
Manages a team of 20+ senior/staff quality engineers worldwide (US, China, Taiwan, Japan, Korea and Europe)
Overall responsibility for interfacing with external customers on all product quality issues
Actively supports automotive product qualifications and assures compliance with AECQ standard
Interfaces with both internal groups (such as Design, Process R&D, Applications and Marketing), as well as external customers for product quality issues
Serves as the key technical contact to communicate product quality issues identified internally as well as from customers with OmniVision’s supply chain (foundry fab, packaging and final test) and drive improvement across the supply chain
Bachelor’s degree (minimum) in engineering, science or related discipline
Minimum 7 years of experience working in semi-conductor quality assurance engineering with knowledge of CMOS Image sensors
Experience interfacing with customers on product quality issues and driving to closure
Some understanding of wafer fabrication process and familiarity with packaging and final test
Knowledge of automotive standards and terminology such as AECQ, PPAP, APQP and FMEA
Familiarity with LCOS (liquid crystal on silicon) is very helpful
Some direct supervisory experience of technical contributors
Excellent written, presentation and interpersonal skills are required

Global Quality Assurance Director Resume Examples & Samples

Primary business partner stakeholders in Singapore, Chicago IL, Redmond WA, Minneapolis MN, Munich GE and Hyderabad IN
SBD stakeholders in Charlotte NC, Ft. Lauderdale FL, Singapore, London UK, Dubai UAE, Raleigh SC, Sydney AU, Paris FR, and Redmond WA
The role will require travel 20-40% for QA LT meetings, Domain/Functional meetings and stakeholder meetings
Demonstrated ability to influence and collaborate with cross-functional teams and realize the business value of a growth mindset
Strong executive presence and demonstrated ability to build, extend and maintain senior stakeholder relationships and be their independent trusted advisor
Disciplined self-motivation, ability to work independently and within a matrixed team environment, with strong execution and attention to detail
Soundly demonstrated data-based decision-making, analysis and problem solving skills
Excellent interpersonal, verbal and written communication, analytical and presentation skills
Familiarity with creating and managing process & standards
Very strong understanding of and skills in the financial – risk-reward – trade-offs in good project management
The successful candidate must be willing to adapt to cross-time zone meetings and travel globally for quality reviews, coaching and connecting with management ~20% of the time
Must have a degree in business with at least 8 years in quality / risk management / services experience. Quality certification expertise (e.g. ISO, CMMI, Six Sigma) strongly preferred. PMP (PMI) certification required. Risk Management certification preferred (e.g. RIMS-CRMP, PMI-RMP)
Trusted Advisor; Building Customer/Partner Relationships
Influencing for Impact
Contracts, Negotiations and Delivery
Judgement
Planning, Organizing and Executing
Dealing with Ambiguity

Quality Assurance Director Resume Examples & Samples

Capable of performing the functions and be knowledgeable of aviation ground safety and management
Shall posses or can qualify for a U.S. states driver license
Shall possess an extensive background in the field of aircraft maintenance and quality assurance with a minimum of 15 years of experience with 10 years of the last 15 years in direct aircraft maintenance repair and inspection
Of the ten years of experience in aircraft maintenance and quality assurance, six years shall be in a supervisory position that included responsibility for assigning quality assurance program workloads as well as performing quality assurance monitoring functions
Must have experience supervising quality assurance personnel supporting scheduled and unscheduled maintenance
Experience writing with clarity and technical accuracy
Must have experienced interpreting technical publications, blueprints, wiring diagrams, aperture cards, and inspection findings; and have complete knowledge and understanding of aircraft logs and records
Shall have sufficient knowledge and experience to effectively assume responsibility for the overall quality of the Contractor maintenance effort in accordance with the CNAFINST 4790.2 Series

Director, Regional Quality Assurance Resume Examples & Samples

In coordination with the VP of Corporate Quality, the other Regional Quality Directors, Quality Assurance and related peers within the Global Quality organization, the Director Regional Quality Assurance will work to lead the successful roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards
Provide leadership and resource management support to Corporate Quality and Affiliates located within regional area
Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GXP guidelines
Ensure Alexion is kept fully informed of new or emerging GMP, GDP and regulatory changes in their region and assess impact of regulatory change on Corporate policies and procedures
Lead the review and implementation of Quality Improvement/remediation plans for their regional Affiliates identified through Quality audits
Participate as a contributing member of the Regional Leadership Team to assure goals and priorities are supported within the Quality System
Provide Quality Expertise and leadership to their designated Affiliate and lead local/regional Quality activities. Assure sites are in a state of inspection readiness and lead support during internal and external inspections/audits. Partner with R&D and PV as required for GVP audits and inspections
In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
Monitor compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
Act as Quality liaison between the local operational groups and Corporate Quality for GMP/GXP/GDP functions and activities
Partner with local, regional and global operational groups to foster a proactive approach to compliance
10-15 years+ of Quality Assurance / Compliance management experience in pharmaceutical/ biotech industry
Strong leadership ability
Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GXP, particularly those related to product distribution as required
Exceptional communication and interpersonal skills
Ability to work globally in a matrix environment
Ability to influence senior management, peers and other colleagues without direct reporting lines
Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
Ability to multi-task and prioritize work

Senior Director of Quality Assurance Resume Examples & Samples

Develop and maintain compliant quality system that adheres to FDA regulatory expectations both internally and with respect to oversight of the company’s suppliers
Responsible for ensuring that all investigational and potential commercial drug substances and drug products are manufactured in accordance with Ardelyx’s requirements and as stated in applicable regulatory filings and in compliance with the cGMPs
Responsible for timely review and release/disposition of drug substance/drug product/clinical trial supplies to support Ardelyx’s company goals
Review and approve analytical/stability protocol, data and reports, maintain stability data base
Oversee qualification, performance tracking, and reviews of contract manufacturers and laboratories and manage internal and external audits
Approve and issue specifications, and methods for drug substances and products
Review and approve IQ/OQ/PQ and validation protocols, tech transfers and reports, as applicable, for all manufacturing, testing, and packaging activities at all CMO’s
Serve as the QA representative on project teams and Head the Ardelyx’s Quality Committee
Support qualification/validation of GxP related computer based systems; support process validation studies and tech transfer as needed
Provide recommendations for corrective and preventative action to the functional area groups/teams
Maintain Quality documentation files, databases, and logs
Work with CMC, non-clinical, clinical, regulatory, etc as an active cross-functional team member to ensure the appropriate document/data integrity for regulatory submission and PAI preparation
Build quality function, with requisite budget and resources to support company’s eventual product commercialization
Oversee GCP compliance with respect to clinical site and CRO audits

Director, PV Quality Assurance Resume Examples & Samples

Assists with the development and implementation of the global, internal Quality Assurance (QA) Program for the assigned region, including attracting and developing QA staff resources to cover the QA Program needs in the assigned region
Maintains an on-going schedule of QA audits in the region to ensure that required levels of audits of various types and timelines for audits are met
Remains current on regulations and guidelines related to the conduct and reporting of clinical trials. Proposes strategies for the implementation of new or revised regulatory requirements for the assigned region, including development of training and/or working with the Training Department to develop training for operational staff on relevant regulatory requirements and revisions to such training
Assists with the development and review of QA procedures, audit plans, checklists, and other tools
BA/BS degree in a scientific discipline or health care field or equivalent combination education and experience
Extensive experience in quality assurance in a clinical research organization or Pharmaceutical/ Biotechnology company
Prior experience with managing and supervising multiple staff schedules and deliverables
Effective organizational, presentation, documentation, interpersonal, and attention to detail skills
Strong and comprehensive knowledge of Good Clinical Practice regulations and guidelines, particularly in the assigned region

Clinical R&D IT Quality Assurance Director Resume Examples & Samples

Lead the strategic development, implementation, application, and continuous improvement of Quintiles TS Delivery Assurance processes and systems meeting both operational and regulatory requirements globally
Lead Quality and Validation function for QTS, with direct or cross-functional management responsibility for global resources and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value of QTS Delivery Assurance related processes and systems
Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on quality and compliance related objectives, plans, and priorities
Keep abreast of the evolving regulatory policy and industry best practices related Quality and Compliance
Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for QTS Delivery Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making
Provide expert advice to leadership and functional area managers on quality, testing and validation, regulatory, compliance, and documentation related issues, including those with department-wide or external impact
Collaborate with functional areas to establish and update metrics that are reported to leadership that highlights risks and key opportunities for continuous quality improvement
Provide Quality, SDLC, and documentation related input to software product development and project delivery processes to maintain compliance with the relevant regulations and international standards
Provide input and resources to author, review and finalize quality-related documentation
Identify and suggest functional improvements to the Delivery Assurance related processes and systems
Partner with teams responsible for Quality and validation software and all other related tools/technologies to support company needs in this area
Support and oversight of corporate CMMI related efforts for QTS including advising project teams on necessary changes to processes, documentation, and associated training
Oversees QTS Quality and Compliance management to ensure internal standards and procedures for Computer System Validation remain effective at delivering compliant IT solutions
Provides guidance to QTS teams on interpretation and application of procedures applicable to the implementation and operation of IT systems
Provides regulatory and software quality knowledge and expertise to support high quality application development and deployment while embracing a risk-based approach
Provide leadership and direction to ensure documentation and testing practices meet applicable regulatory requirements, company policies and quality standards, using sound computer system validation and QA testing practices
Provides oversight and approvals of risk assessments related to IT systems and platforms
Collaborates with corporate Quality and SCO functions for pre-audit and audit planning, support for internal and external audits, and leadership and oversight for potential findings and CAPAs from audits
Works with project managers to establish work scheduling plans in support of project schedules. Provides resource estimates for QA and validation efforts related to project and budgetary planning
Manages resource allocation to approved projects and ensure project timelines are met
Monitors new and emerging regulatory requirements and good practice guidance for GxP computerized system, IT controls and compliance
Bachelor degree in Computer Science, or engineering or related field
Minimum 12 years of experience in Delivery Assurance or QA leadership and management roles with direct or cross-functional management responsibility for personnel and responsibility for a broad spectrum of Pharma Software Development and/or Solutions and Services Delivery related Quality and Compliance elements
Demonstrated success leading cross-functional development, implementation, application, and maintenance of Delivery Assurance processes and systems
Strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
Detail-oriented with strong organizational skills and high quality standards
Good interpersonal and verbal communication skills, with the ability to effectively communicate with employees, functional area and executive management, customers, and business partners
Is considered an expert in computerized system lifecycle management and has experience in the application of industry best practices
Well versed with regulatory compliance (GxP, 21CFR Part 11, CMMI, EU Annex 11 etc.)
Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP-5, NIST, ICH
Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause
Experience in participating in regulatory inspections, presenting/defending IT functions in audits or regulatory inspections
Bachelor’s Degree in Computer Science or related field; with 12 years IT experience including previous management experience or equivalent combination of education, training and experience

Director, Sales Quality Assurance Resume Examples & Samples

1 Provides consultative support to Sales and Owner Services in developing appropriate quality assurance standards and measurements that track outputs to standards
2 Reviews Major Projects and understands the impact of key organizational deliverables on the change landscape
3 Implements enhanced quality assurance routines in concert with the lines of business to ensure that materials provided in response compliance reports and rescission feedback are complete, fully responsive and meet quality standards
4 Builds an effective and productive relationship with Owner Services and Sales leaders that drives accountability within the lines of business as well as pushing back and negotiating where appropriate on topics of response timing, content to be delivered, etc
5 Creates continuous service improvement loop to ensure root cause of any issues during the change and that lessons learned are documented and available
Ability to prioritize and organize tasks required to manage projects
Change management skills
Microsoft PowerPoint - Executive level presentations
Strong knowledge of the Change Management processes and tools
Strong knowledge of Project Planning and Management tools
Ability to interface and influence Executive management. Takes and gives coaching (team player) Strong conflict management skills
Strong analytical and problem-solving skills with attention to detail
Working knowledge of Regulatory Compliance and Operational Risk Management
7+ years directly related business experience
3+ direct work experience Sales Compliance

Director of Quality Assurance Resume Examples & Samples

Lead and manage a QA team of employees in Canada involved in new product development
Build, manage, define and implement the QA methodologies, processes, procedures, systems and schedules that will ensure delivery of predictable, high-quality product releases
Define and drive the testing strategy and plan from requirements through product release, including regression, functional, exploratory, and other testing
Intelligently build automated and manual test suites to drive efficiency and productivity throughout the organization
Inspire confidence and add additional leadership strength to the broader management team

Quality Assurance Director Resume Examples & Samples

Establish and maintain systems, policies and procedures to ensure product quality and compliance
Lead the Quality Assurance team to ensure that company priorities and timelines are met
Lead monthly Quality meeting and ensure that relevant metrics are defined, presented and reported in meeting minutes
Work with cross-functional validation teams to ensure that validations fulfill regulatory and laboratory director requirements
Maintain all Clinical Laboratory regulatory licenses and ensure renewal of licenses as required
Work with regulatory agencies to ensure the laboratory environment exceeds standards and prepares and coordinates laboratory inspections
Manages and maintains the document control system
Ensure that SOPs, logs, validations, worksheets and other quality records are reviewed and approved
Establish software/bioinformatics pipeline documentation
Lead sponsor and regulatory audits/inspections
Performs and documents internal audits and makes recommendations for corrective actions
Ensures proper evaluation and completeness of investigations, root cause analysis as well as corrective and preventive actions (CAPA)
Ensure compliance with current applicable regulatory requirements
Train personnel on Quality System policy and procedures
Track and trend planned and unplanned deviations, out of specification quality control results, complaints, and corrective actions
Minimum 5 years Quality Assurance experience in the medical device and/or clinical laboratory environment, understanding of product development, quality control and services
Minimum 3 years QA supervisory experience. Experience in establishing CLIA, CAP and/or QSR Quality Systems, experience with ISO 15189 is a plus
Experience working in CLIA-certified and CAP-accredited laboratory settings and operations
Experience working with software engineering and bioinformatics team to implement processes
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, change management, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management, etc
Extensive experience with high-throughput laboratory operations
Experience in a start-up environment
Dynamic individual with the ability to communicate and engage others
Self-Starter

Senior Director of Quality Assurance Resume Examples & Samples

You'll lead the department in the area of QA testing methodologies through to implementation
You will provide subject matter expertise in the Quality Assurance discipline in order to define/improve the ICS QA process
You'll be responsible for the hands-on, daily management of 8-10 direct report staff workload
You will handle the active resource management and allocation of project assignments of the QA staff ensuring their deployment on key projects is on time
You will prioritize, handle, and execute multiple tasks, define problems, and resolve issues with limited supervision from senior management
You'll provide project management and oversight on project scope and testing strategy. *DICE_TA *LI-ME1

Director of Quality Assurance Resume Examples & Samples

10+ years of progressive experience in a Supervisor / Management role within a Hospital or other Healthcare related organization
3+ years of Utilization Review experience; 3+ years of experience in a Quality Management position
Master's Degree in a related field
Certified Professional in Healthcare Quality (CPHQ)
Solid assessment, clinical, and documentation skills

Quality Assurance Director, Middle East Resume Examples & Samples

Responsible as the Lead Quality Custodian for the Middle East Region and bring Quality Leadership within the region’s offices by enforcing the AECOM quality system and policies
Responsible to ensure consistency between the project management and quality systems implementation within the region’s offices and projects, including any updates presented from EMIA and Global levels
Responsible for liaising and guiding the business lines within the Middle East offices for quality related matters
Responsible for liaising and guiding the Project QA Representatives within the region on quality related matters
Responsible for ensuring that the QA Representatives properly maintain complete and accurate documentation within the region and is passed on to the Centralised QA Admin Team in a timely manner
Responsible for coordinating and monitoring the execution of the internal quality audit programme by the QA Representatives on the Country Offices and selected projects, and assist the Lead Auditor EMIA with the external third party certification audits as needed
Responsible for ensuring the Monthly Quality Reports (corporate and project KPI data) is collected by the Centralised QA Admin Team from the Middle East QA Representatives and evaluate to identify performance, trends and issues, and areas for improvement which are summarised and presented to the Middle East Management and the QA Director EMIA for review
Responsible for ensuring that the required quality awareness is presented to the region’s offices and QA Team
10 to 15 years’ experience within a similar role
Minimum 5 years’ experience as a Lead Auditor
High level strategic management and organizational skills
Excellent working knowledge of industry practices/safety/quality management systems
Experienced in statistical reporting including KPIs and trend analysis
Excellent communication skills using the English Language
Civil Engineering Degree or a related field, incorporating quality qualifications
Certified Lead Auditor for ISO 9001 (latest version), with ISO 14001 and OHSAS 18001 (latest version) as a plus

Quality Assurance Director Resume Examples & Samples

Provide the overall leadership in the areas of quality management systems, regulatory compliance, quality control laboratory functions, documentation control, quality audit functions, both internally and with contract manufacturers and packagers. This includes assuring that all product specifications and all regulatory requirements have been satisfied prior to the final release of any product into the distribution channel
Responsible for developing/ deploying the Quality strategic plan and assuring the integration/ alignment into commercial quality strategy
Interfaces with commercial president in areas of quality decisions, such as escalations, field actions and or other significant quality issues
Act as the primary interface with international, federal, state and local regulatory officials in regards to the manufacture and release of any drug product and medical devices by Reckitt Benckiser North America
Ensures QMS supporting commercial businesses are in constant state of readiness for planned and ad hoc regulatory audits or inspections
Provide leadership to the quality organization that has the final responsibility for the release of any product by Reckitt Benckiser North America. The release criteria includes the review and acceptance of all testing data supporting the release of the product against specification; the review and approval of all documentation generated during the manufacturing and packaging processes; and the overall compliance to cGMP guidelines during the receipt, storage, manufacturing, packaging, and testing of the final product
Assure that all complaints involving product quality are thoroughly investigated, examined for trends, reported to senior management, and effectively addressed by corrective and preventive actions as deemed appropriate. This position also provides leadership in any recall situation
Assure that annual reports for commercial products are completed in a timely basis
Follow Hazardous Waste, General waste and Recycled Waste management and Disposal procedures. Supports Safety, health and Environmental by complying Company policies and procedures regarding safety and employee conduct
Bachelor’s degree in a scientific or technical field (i.e.Chemistry, Chemical Engineering,
Material Science, etc.)
Demonstrated ability to act in a leadership capacity developing and implementing business / quality processes and strategies, leading managerial and professional technical personnel, and coordinating the execution of multiple complex projects in a fast paced environment
Must have a strong working knowledge of applicable parts of Title 21 of the CFR and significant leadership / managerial responsibility for quality systems development and maintenance in the pharmaceutical or medical device industry
Must have experience with quality tools such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Root-Cause Analysis, Six Sigma, cross-functional problem solving teams, etc
Ability to deal confidently and effectively with agents of governmental regulatory bodies as well as internal and external customers and suppliers
Must exhibit excellent communication and facilitation skills, both oral and written

Director, Clinical Quality Assurance Resume Examples & Samples

Serves as the Clinical Quality Assurance leader in Europe in the implementation and refinement of processes to ensure that Takeda maintains sponsor oversight of the quality of its development activities in compliance with applicable regulatory requirements
Collaborate with the Senior Director, Clinical Quality Assurance, Americas and Europe to develop and implement the strategy for sponsor quality oversight of regional development activities
Develop regional Quality Management plans for development programs, and tactical audit plans
Analyze audit program results, quality issues and investigations in order to identify actionable trends and to promote a state of compliance
Identify compliance issues and conduct investigations for regional development activity. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution
Manage inspection readiness activities and represent Takeda as a clinical quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies. Ensure that clinical inspection commitments are fulfilled on time
In collaboration with R&D Clinical Supplier Quality, determine acceptability of clinical suppliers for potential use by Takeda
Serve as a member of the Clinical Quality Assurance Leadership team, giving input to key strategic decisions
Ensure strong alignment with R&D Quality Systems and Compliance and R&D Quality Services and Improvement
B.Sc. in Science, Nursing, or related scientific field. M.Sc. preferred
Extensive applicable pharmaceutical and/or biotech development experience with a solid understanding of GCP-related Quality Assurance
Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for clinical trials and to assure the ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states
Must be able to manage all tasks assigned and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines

Director, Pharmacovigilance Quality Assurance Resume Examples & Samples

Serve as the Pharmacovigilance Quality Assurance leader in Europe in the implementation and refinement of processes to ensure that Takeda maintains oversight of the quality of its pharmacovigilance activities in compliance with applicable regulatory requirements
In collaboration with R&D Pharmacovigilance Quality Assurance develop tactical and strategic audit plans
Identify compliance issues and conduct investigations for regional pharmacovigilance activity. Elevate serious and/or systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution
Manage inspection readiness activities and represent Takeda as a Pharmacovigilance quality subject matter expert during health authority inspections of the sponsor. Provides strategic direction to assure that responses are timely and appropriate to maintain Takeda’s good standing with regulatory agencies. Ensure that Pharmacovigilance inspection commitments are fulfilled on time
In collaboration with R&D Supplier Quality, determine acceptability of Pharmacovigilance suppliers for potential use by Takeda
As assigned, conduct due diligence assessments of prospective in-licensing opportunities and acquisitions to identify key quality assurance and compliance risks. Conduct document reviews and on-site assessments as required
Extensive applicable pharmaceutical and/or biotech pharmacovigilance experience with a solid understanding of GVP-related Quality Assurance
Auditing Knowledge: Demonstrates advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity
Communication skills: Must communicate professionally, clearly, concisely and consistently to external and internal customers, both verbally and in writing. Must demonstrate professional presentation skills and deliver informative and balanced presentations and, when applicable, facilitate resolution of differing opinions
ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel will be required
Requires approximately 50 % travel
LI - MD1 - EUR

Claims Quality Assurance Director Resume Examples & Samples

Effectively plan each review including review date range and communicating review scope to appropriate parties
Keep the appropriates parties advised of the status of the current review results while recognizing and communicating trends, training needs, compliance requirements or process reviews required
Perform effective wrap-up meetings with the appropriate parties specifically identifying any follow up activity such as training, communication updates, compliance, and process review requirements
Assist with coordinating with IT, Compliance, and Internal Audit with necessary updates, changes or communication needs
Complete follow-up reviews as necessary to determine whether deficiencies are corrected
Manage various Claims Software Systems (adding and removing users/clients, maintaining accurate authority levels, etc.)
Monitor shared drive reporting for Claims Exception Reporting, Direct Check Reporting and Claims Monthly Management reporting to ensure processes are completed timely and accurately in order to ensure compliance with internal audit controls
Oversee all compliance processes for state as well as federally mandated reporting systems
Assist with other Business Analyst Projects as needed including Vendor Management, Data Analysis, Presentations, and Training Developments
Manage Claims QA Unit and provide direction as required
Review and evaluate review process to meet company needs
Mentor and coach Claims QA associates to develop skills, increase job knowledge and achieve stated performance objectives
Set goals and objectives for staff, providing quarterly and annual appraisals
Collaborate with Claims Operations to identify and prioritize key risks
Identify primary controls, key metrics and best practices
Develop and implement advanced systematic monitoring and assessment of process compliance that emphasizes root cause analysis and continuous improvement of claim outcomes
Independently analyze claims data and identify patterns and relationships within data sets
Conduct testing, document findings and develop written recommendations
Assist with the design and implementation of changes to policies and processes
Assist in supporting and evaluating existing or new systems/programs
Assist with coordinating with leaders in all relevant departments in maintaining and expanding Quality Assurance’s role as needed
Establishes and executes controls to ensure that the quality of the auditors work meets or exceeds standards
Extensive experience with non-standard automobile insurance operations is a plus
Team player with a strong collaborative orientation; ability to build strong relationships across an organization
Excellent interpersonal skills including strong verbal and written communication skills and ease in interacting with associates
Strong analytical and technical skills
Creative problem solving and critical thinking/decision making skills
Organized, detail oriented and a self-starter
A minimum of five years of audit, process improvement, project management, analytics and/or quality assurance. Claims experience is preferred

Director, Post-marketing Quality Assurance Resume Examples & Samples

Ensure quality systems are compliant with corporate and site procedures as well as industry standards
Drive continuous improvement initiatives
Facilitate, participate, review, lead and/or approve investigations, root cause analysis, change controls, etc
Effective coordination of functions across the site and with externals to drive timely review, approval, and closure of investigations, change controls, corrections, and effectiveness checks
Promote and induce quality mindset culture in SSF
Manage and supervise US QA function
Maintain close working relations with all relevant business units in SSF, in particular Market Access, Drug Safety, Medical, Regulatory, Legal, Marketing, with the aim to strengthen Quality and provide consultation
Assist business units in establishing robust quality procedures and training activities
Write and maintain SOPs pertaining to SSF QA function in alignment with PMQA processes
Evaluate and assess deviations
Perform QA relevant training to staff on audit, root cause analysis, CAPA handling and Good Documentation Practices
Manage and oversee all local GxP audits and assessments, including but not limited to PV, REMS, GMP audits at Specialty Pharmacies, inpatient pharmacies, and data/IT audits (AIM). Note: audits and assessments related to GCP and hub services remain with PMQA/CSV QA respectively
Establish effective lines of communication with relevant business functions (Market Access, Application and Information Management, Drug Safety,…); and ensure timely notification of GxP activity outsourcing plans by business functions
Apply risk assessment methodology to define audit need and periodicity of audits
Assess and select contractors performing audits on behalf of Actelion SSF and act as their contract giver
Ensure proper root cause analysis / CAPA follow-up, involving business function
Act as host to GQM audits (PMQA, CSV QA) and coordinate coEstablish and maintain inspection readiness processes including set up of team managing inspection requests ("war room")
Host FDA inspections at Actelion SSF, in collaboration with DS
Oversee all interactions during inspections including provision of documentation, briefing/ debriefing with irresponding CAPAs with CAPA owners
Master’s Degree in Science (Chemistry, Microbiology or Biology preferred) ; Advanced degree preferred
A minimum of seven to ten years related experience and/or training and/or equivalent combination of education and experience in Quality Assurance. Prior Quality Assurance experience is required
Strong knowledge and experience in in quality assurance (QA), pharmacovigilance (PV), REMS
Solid understanding of US and international PV regulations and guidelines (CFR, ICH...) as well as their practical implications
Experience with hosting FDA inspections, familiar with FDA working processes
Strong leadership, communication skills
Persuading skills
Excellent organizational and leadership skills, and ability to work under pressure and tight timelines
Thorough knowledge of domestic and international regulatory reporting requirements

Director Product Management & Quality Assurance Resume Examples & Samples

Manage daily relationship with technology vendors involved in releases for brand and corporate websites, identifying recurring and ad-hoc deliverables, driving quality and timeliness of deployments with minimum defects
Create repository of business requirements to document the functionality behind all sections of the transactional sites, and review/approve requirements for new functionality and site defects
Drive strategy and manage maintenance of digital platforms and integration processes for continuous reliability and revenue growth
Define testing strategy, success criteria, structure test plans and testing materials, engaging with stakeholders across the company to assign testing tasks and drive successful completion when software releases are deployed
Plan required steps on the Digital Products, IT and Vendors for a regular and effective release management process, working with appropriate teams to update functional requirements and perform user acceptance testing
Define cadence for triaging and prioritization of defects, leading internal and external teams to assess effort, revenue impact and technical and business dependencies
Hire, develop and train team to achieve high performance practices
BA/BS in Computer Science or Business required (MBA is a plus)
6+ years of experience in internet platforms, ideally in transactional websites with solid knowledge of shopping/retail functionality, cloud technology and API connectivity
3+ years of experience leading functional or technical teams
3+ years of experience with software testing and Quality Assurance
2+ years working in Agile software development working practices
3+ years of experience with third party integrations and management of technology vendors
Solid understanding of web and mobile technologies and the innate curiosity and desire to learn more
Passion for travel; experience in hospitality or retail is a plus

Director, GMP Quality Assurance Resume Examples & Samples

Develop and direct consistent QA programs within the NA Biologics operation, ensuring compliance with cGMP and other pertinent federal and state regulations, international standards, corporate policies, and customer requirements
Working with the Senior Director of Global GMP QA to coordinate site compliance and global quality programs to help assure consistency
Manage the cGMP NA Biologics QA functions in support of multiple domestic sites/locations
Provide assistance on global GMP programs/goals to ensure proper harmonization across the sites
Participate in the CRL Global QA meeting, Corporate QA/RA policy development, joint Operational/QA meetings and strategic planning sessions
Assist in the development and implementation of audit programs, including both internal and external auditing, in support of the NA Biologics business segment
Provide regulatory guidance to internal departments for the development of test methodology, new facility construction, new manufacturing process, etc
Prepare regular compliance reports that advise management of the state of compliance within the NA Biologics facilities
Direct and mentor the Quality Assurance staff supporting NA Biologics operations
Identify and develop high-potential employees, through development plans, in support of the company’s succession planning process
Ensure that management training and development needs are identified and programs initiated. Direct the development of departmental orientation and other training programs
Monitor performance of direct reports. Provide regular coaching and counseling. Prepare and deliver salary and performance reviews; review and approve performance and salary appraisals initiated by direct reports
Develop short- and long-range operating objectives, organizational structure, and staffing requirements. Oversee the development of a departmental plan for backup and succession of key departmental personnel
Education: Bachelor’s degree (B.A./B.S.) or equivalent in scientific or related discipline/field

Senior Director of Quality Assurance Resume Examples & Samples

Takes ultimate responsibility for the direction and effective management of all departments within the quality assurance function, ensuring that each department is resourced, structured and managed to support the goals of the organization. Departments include, but not limited to
Calibration * CAPA
Compliance * Document & Data Control
Internal / External Quality Audit * Quality Control, Product Release
Management Review * Quality Inspections
Quality Engineering * Real Time Aging
Field Assurance * Risk Management
Supplier Quality
Validation (Product & Process)
Assigned Quality System Management Representative for Merit Medical Systems Inc.; primary regulatory agency and customer contact on all quality related queries globally e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements
Instrumental in setting strategy to enhance and maintain Merit Medical Systems Inc. Global Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, and global markets served e.g. US, South America, Canada, EMEA, APAC, CSR (Customer Specific Requirements)
Key member of Senior Leadership Team that manages, develops and drives Merit Medical Systems Inc. to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development
Promote, support the "Merit Business Excellence System" Program; lead by example; partner with functional leaders to ensure that this program, the organizations objectives and values are at the forefront of decision making and action
Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction
Develops capital plans and budgets for the Quality Assurance Department
Provides Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer by
Developing and directing annual 'Quality Assurance" team goals to deliver the key company objectives and continuous growth of personnel
Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives
Preparing or reviewing written procedures and documentation for testing and manufacturing processes
Tracking information about customer complaints to provide design, development and operations teams with product quality information
Providing recommendations and decisions regarding the disposition of non-conforming products; determines when Regulatory/Clinical approval is required; stops production lines if problems with quality arise and initiates preventive and corrective actions to ensure non-recurrence
Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations
Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies
Partner with Research and Development (Product & Technology) function ensuring
Customer requirements are met
Safe and effective product design
Compliance with design control requirement
Design for manufacture
Quality at source
Smooth transition of new products and Technologies to operations groups
Participate, support and provide independent review of all verification and validation activities
Functional manager for a team of quality assurance personnel
Resource functional areas, projects with the required resources
Select, coordinate assigned work, mentor, manage performance for all team members ensuring appropriate corrective action for sub-optimal performance, and recognition of strong performance creating avenues for advancement
Manage training and career developmental needs of team to the benefit of the individuals and the organization, ensuring that talent is positioned and utilized for maximum effectiveness
May fill in for Vice President, Global Quality or similar position, as directed
Lifting -- Not to exceed 50 lbs. -- local practice may apply
Writing
Sitting
Standing
Bending
Vision
Color perception
Depth perception
Reading
Field of vision/peripheral
Solid communication skills in English (Must) , Portuguese or Spanish is a plus
Education and/or experience equivalent to a Bachelor's Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher)
At least ten years of work related experience, of which a minimum of four years' experience in a related management role
Proven track record in leading organizations through external inspections / audits (e.g. FDA, Notified Bodies, Competent Authorities, and Customers)
Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), ISO 13485 Quality System Standard, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), ANVISA and JPAL/JGMP
General knowledge of the medical device industry and the applications of Merit's products in the medical field
Post graduate diploma/Master's degree in Quality Management
Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools
Strongly prefer medical device manufacturing management experience
Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions
Strong leadership ability and the ability to influence at all levels within the organization
Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others
Ability to provide functional, cross functional and organizational leadership as required by the demands of the role
Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively. Attention to detail without losing site of the big picture
Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process

Clinical Research Quality Assurance Director Resume Examples & Samples

7-10 years of clinical research experience
4-7 years of management leadership
Excellent problem-solving abilities
Strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation
Superior time management, administrative and computer skills
Experience related to Human Subjects Protection (including 21 CFR and 45 CFR 46 of the US Code of Federal Regulations), GCP and GMP standards, FDA/EMA requirements, Quality Standards and Systems, and HIPAA

Director of Quality Assurance Resume Examples & Samples

Advanced working knowledge of QA processes and methodologies; expertise in test planning, test case management, code coverage and defect analysis
Experienced in project management and Agile product development life cycles
Proven experience working for an established software vendor
Collaborative but decisive personal style; highly effective communicator and problem solver
Experience with complex business processes
10+ years of quality assurance experience including test planning, implementation and execution, on an enterprise Windows desktop application

Director of Quality Assurance Resume Examples & Samples

Establish Testing Centre of Excellence
Direct the detailed analysis of quality assurance processes within the company, including gathering data, investigating cause-effect relationships, and measuring process performance
Engage cross-functional project teams to develop, deploy and measure several concurrent quality process improvement projects and initiatives that will contribute to a comprehensive integrated quality assurance program
Develop business cases and obtain executive-level support and approval for implementation
Identify and apply industry best practices and benchmarks to develop "best-in-class" QA process models and target performance metrics
Implement, track, and continuously improve metrics and reports to support both business process improvements and operations across the company
Overall accountability for test processes, test planning and resource management including
Functional testing for integration, regression
Testing for all changes to production
Ongoing improvements to processes, timelines to obtain efficiencies
Media Testing
Manage external vendors who are engaged to perform testing on Rogers’ behalf
Manage Vendor SLAs and KPIs,
Challenge vendors on test execution strategy and to provide proof of Knowledge transfer amongst team members
Deliver ways to Improve test execution through automation
Proactive and comprehensive reporting
Lead not just manage the team
Post-secondary education in IT, Engineering and/or related process improvement experience is desired
10+ years of progressive experience within IT and QA, including Performance Testing
Proven track record for defining and implementing testing efficiencies
Experience in creating, improving, or managing an end to end Quality Management Program
Experience working with a matrixed team of directors and managers
Experience in managing and working with testing vendors with on and offshore teams
At ease with influencing the different levels of the organization, from managers to vice-presidents, within own function and across functions/LOBs
High level of comfort working with and interpreting data
Strong interpersonal, communication (written and oral) and presentation skills
Energetic self-starter who thrives in a fast-paced environment

Director, Global Brand Quality Assurance Resume Examples & Samples

BS/MS
Demonstrated success in handling multiple cross-functional projects, new product development process, and project management. Demonstrated communication, leadership and human relations skills - able to work well with all elements within and outside of the organization
Computer literate with good working knowledge of Microsoft products. (SAP knowledge an added advantage). Strong interpersonal, communications (oral, written, influence and persuasiveness), technical report/writing and presentation skills
Ability to travel for 3-4 day periods on short notice

Quality Assurance Director Resume Examples & Samples

ISO 9001 Audit Systems with internal audit controls and procedures
Supplier Certification and Quality Control
Records Retention
MRB management of excursionary material
Sub-contractor audits
Minimum of 10 years experience within the semiconductor industry, preferably within a Quality Assurance organization
Proven track record of leading teams and projects to successful completion
Understanding of ISO9001 control systems and standards
History of interacting with suppliers and sub-contractors in a production environment for the purpose quality control
Legal ability to travel internationally

Quality Assurance Director Resume Examples & Samples

Quality standards ISO13485 & MDD etc
FDA Regulations & Guidelines, 21CFR820, cGMP/QSR,
Excellent knowledge of management systems
Excellent knowledge of Quality Assurance and Quality Control processes, Continuous improvement processes, Quality systems, Supplier Quality Assurance practices
Change management/processes
Managing Team building skills
Knowledge of systems: E.g. Microsoft Office, Oracle, & Windchill Document Management Systems
Minimum of 15 years experience in QA/QC, preferably in Medical Device Manufacturing. Will have a minimum of 15 years progressive experience with quality processes and systems in a regulated environment (life science) within an international fast growing/changing environment. Experience must include influencing and directing the work of others both functionally and cross-functionally

Director of Quality Assurance & Delivery Owner Resume Examples & Samples

Overall accountability for strategic alignment of quality and the business
Overall accountability for high quality product value deliverables to support line of business strategy
Foster relationship between the quality delivery organization and the line of business
Accountable for alignment of technical deliverables to policies, standards and best practice guidelines
Change agent for promotion to compliance to quality policies, standards and best practice guidelines
In close collaboration with the LOB technology team and the QMS COE QA and the strategic partners, ensures the testing technology stack available for each test team is the most effective and efficient for the architecture and design deployed with that LOB’s products, projects, work packages and M&PS efforts
Responsible for establishing and clearly communicating the overall test strategy to the QMS and Technology Leadership Team and aligned with key business initiatives that could consist of cloud computing, technology transformations, strategic architecture direction, and shift-left methodologies
In coordination with the QA COE the QDO is responsible for establishing the strategy that may consist of, but not limited to, data management and refresh schedule, production staging environments, alpha and production checkout nodes, test system integration with up-line and downline code and system configurations including customer test systems, continuous integration and continuous deployment support, end-2-end testing and monitoring and cloud implementations, cross LOB integration efforts, and cloud based tools
Directs the implementation of continuous quality improvements across the team to improve reliability of test systems, improved speed in remediation of issues, closer alignment with product delivery requirements, and proactive measures to improve overall product quality that will result in reduced impact to project schedules and cost related to those delays

Quality Assurance Director, Devices Resume Examples & Samples

Ensures teams work closely with design, development, quality, regulatory, and supplier/contractor teams to establish and document the master verification and validation plans in conformance with the system design specification and sound testing principles
Oversees or assists in planning, coordinating and execution of design verification and validation testing to directly support the master verification and validation plans
Ensures teams work closely with the engineering team to establish and drive the design FMEA, FMECA and other risk related activities (ISO14971)
Ensures inspection readiness and documentation robustness for programs/products in scope and for Device Quality processes
10+ years of business experience, leading technical organizations in multiple parallel and virtual environments

Tax Quality Assurance Director Resume Examples & Samples

BA or BS in Accounting, Finance or Business preferred
MST preferred
CPA certification required
8+ years of tax compliance experience within a public accounting firm
Comprehensive tax consulting experience and demonstrated expertise in taxation and knowledge of federal and state tax laws and regulation
An ability to effectively present information and appropriately respond to questions from clients and team members
A track record of successful new business development experience a plus
Excellent analytical, supervisory, organizational, and written and verbal communication skills necessary
Experience and continued interest in developing and mentoring junior team members
Proficiency in MS Word, Outlook and Excel required
Experience with ProSystem FX Engagement preferred
Ability to travel as required by business

Director, Service Desk & Quality Assurance Resume Examples & Samples

Identifies and helps to create training curriculum for new and current users of basic processes of the ticketing systems
Drives initiatives to improve and align organization's quality of services, operating model and mindset
Establish, measure and exceed service standards and key performance metrics
Manages escalations, ITSM initiatives and projects
Owns and manages the partnerships with key business stakeholders from divisions and corporate on business operations
Able to lead cross-functionally and inspire technical people to 'wow' their customers
Acts as liaison between business and vendor to drive towards meeting business requirements
Is familiar with Net Present Score for customer satisfaction
Determines and delivers metrics not only within the SupportNow organization but across the entire IITS organization
Drives automation efforts both from within Comcast and with the vendor
Owns and manages contract details and understands if and what might need to be updated
Provides weekly updates to leadership and recommends courses of action to resolve any issues or concerns
Owns process improvements initiatives and reports on metrics
Owns the Customer Experience and drives continuous improvement efforts
Performs other duties and responsibilities as assigned

Corporate Quality Assurance Director Resume Examples & Samples

Provides strategic leadership for corporate quality improvement initiatives
Acts as point person for quality and regulatory interactions with sponsors and regulatory agencies
Member of Bioclinica’s Corporate Regulatory and Quality Governance Committee
Champions process and tool improvements to facilitate comprehensive data and metrics collection projects within Quality Assurance and Regulatory Compliance
Leads and directs corporate compliance activities and teams
Provides leadership and champions Bioclinica’s Quality Assurance and Regulatory Compliance standards
Provides leaderships in ongoing process improvement, process standardization and integration efforts that evolve Bioclinica’s Quality Management System (QMS)
Provides QA and Regulatory consultation on systems development, policies and procedures as well as resource planning and staff development
Contribute to industry committee activities (e.g. ACRO, AVOCA, TransCelerate etc.)
Oversees and directs compliance reviews and internal auditing programs
Implements continuous improvement activities to ensure ongoing compliance with the changing regulatory environment
Mentors and provides guidance to departments on implementing and maintaining compliant processes and software validation best practices
Actively leads and/or participates in management committees and special projects to ensure quality and compliance are built into the company’s activities
Champions Bioclinica’s Quality Manual and associated documentation
Collaborates with stakeholders in the development of operational training materials and development programs
Supports the implementation and improvement of the corporate performance management program
Supports the design, development and implementation of effective Quality Management Systems for Bioclinica’s Corporate-Wide
Excellent documentation and organizational skills
Excellent analytical skills and the ability to work independently
Leadership skills and personal qualities to be successful within a matrix organization
12+ years of experience in regulated environments
Sound knowledge of clinical research environments
Sound knowledge of GxP regulations and guidelines
5+ years management experience in quality assurance and quality systems
5+ years of experience in computer validation processes in regulated environment including 21 CFR Part 11, Annex 11, Japan ER / ES

Quality Assurance Director Resume Examples & Samples

Manage delivery for QE & A from Client location and serve as the first point of escalation
Accountable for overall delivery across multiple projects in the engagement
Anchor and drive the steering committee meetings about the delivery status for all projects
Regular connect with Clients at VP, CTO and CIO Levels for the delivery and identifying new opportunities (organic / adjacent)
Liaise with verticals and other horizontals to bring in synergies and ensure successful delivery
Tracking and supporting the activities of project teams to ensure quality and timeliness of program execution
Responsible for reporting SLAs, metrics and other critical hygiene factors that impact the Account
Ensure engagement objectives are in continuous alignment with the evolving business direction
Get first-hand customer information and uses it for improvements in services provided by Cognizant
Should be aware of how strategies and tactics work in the client’s environment with knowledge of Cognizant’s competitors as well as broad drivers in client’s business
Expected to have high level technical & functional knowledge to explain business problems to Cognizant internal teams and cascade information in most lucid form
Assist account managers/client partner in related business development activities to grow mindshare and market share in the account
Review solution and estimate for new opportunities
Should be able to tactically handle internal escalations among project teams
Reporting to our internal senior management or Leadership teams on the overall engagement (across different dimensions like delivery, bid management, staffing, financials etc.)
Customer facing experience with background in Health Care
Extensive hands-on experience in handling large organization wide transformational programs
Should have excellent presentation and written communications skills
Strong analytical and negotiation skills
Works independently to manage the whole program and respective stakeholders/ and projects
Has ownership for key projects’ timelines, deliverables, budget and metrics
Project/strategic planning and business background with understanding of assigned areas of responsibility
Ability to multitask and react in a fast-paced organization

Assoc Director External Quality Assurance Resume Examples & Samples

Bachelor degree in Chemistry, Pharmacy, Biology, Microbiology, Logistics, Supply Chain Management, or Engineering
Must have expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements
Must have excellent problem solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments; must be able to apply sound risk management
Must have the ability to influence management of complex operations, protecting company image and reputation with patients, medical stakeholders and regulatory agencies
Must have strong demonstrated interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of cultures on non-routine matters in stressful situations. Able to handle organisational complexity and ambiguity
Must have exemplary people/team collaboration experience, including speaking candidly, and motivating teams

Quality Assurance Director Resume Examples & Samples

Experience directing Quality Assurance organizations through DevOps and Continuous Delivery transformations
Strong knowledge of financial industry and Custody, Clearance and Settlement businesses, processes, disciplines and standards
Excellent written, listening, presentation and interpersonal skills
Ability to work independently, motivate, prioritize and execute tasks in a high-pressure environment
Willingness to work in a fast-paced and dynamic environment where daily, weekly software updates coincide with major project releases
A strong understanding of Application Development Life Cycle and various software development lifecycles including DevOps, Agile and Iterative
Working knowledge of Java; Database/SQL; MS Visual Studio.NET; Perl; Python; Data Quality; Container Technology

Quality Assurance Director Resume Examples & Samples

Academic degree
Several years of experience within the area of Quality Assurance Management
Strong track record from the food ingredient industry, food industry or pharmaceutical industry
Strong managerial experience
Experience from driving change, promoting process improvement, developing standards and managing processes

Director of Financial Quality Assurance Resume Examples & Samples

Expert in finance, healthcare revenue recognition, accounting, risk assessment, operational and financial controls, including Sarbanes-Oxley, and cost control principles including Generally Accepted Accounting Principles
Demonstrated experience in audit planning and execution
Knowledge of change management
Knowledge of automated financial and accounting reporting systems
Knowledge financial regulations and standards
Ability to analyze financial data, reports, statements, and projections
Ability to motivate teams to produce quality materials within tight timeframes and simultaneously manage several projects
Expert at facilitating group meetings
Five years of manager or director-level supervisory experience in finance, audit, or accounting required

Program Effectiveness & Quality Assurance Technical Director Resume Examples & Samples

Guide and support the two NOs QA leads in strategy review, monitoring and tracking
Lead the adaptation of the two NO programs to SAR sector focus and the new global strategy by keeping track of global and regional focus guidance
Ensure alignment of strategy to programs through the LEAP-3 adoption process, recommending necessary adaptation, rectification and changes and proper integration of newly joining programs within the greater strategy focus of the two NOs
Ensure the two QA leads are technically supported to produce high quality CWBRs on their strategies
Strong monitoring framework, systems, capacity with clear roles and responsibilities for data capturing, aggregation, reporting and utilisation including facilitation of reflection processes internally and with external stakeholders including communities and partners
Ensure rigorous baselines and evaluations are conducted for Technical Programmes (TPs) and grants
Ensure that consultancies are properly managed in all design, baseline and evaluations
Promote innovative methods for data collection, reporting and utilisation to create efficiency and improve data quality
Develop and execute evidence building plans and enhance the NOs evidence base in quality, diversity and breadth of coverage
Ensure Horizon-3 utilisation to maximum benefit of building evidence, management of knowledge and integration of sponsorship and programming
Enhance Design Monitoring Evaluation (DME) capacity in capturing change among vulnerable children
Identify and collaborate with research institutions and universities for enhancing capacity and quality of evidence in the National Offices (NOs)
Develop networks with peer institutions to reduce duplication of data gathering, share WV’s works and evidence and profile the organisation as a leader in the area of evidence
Promote NO QA staff participation in relevant CoP to improve engagement and learning within WVI
Ensure key organisational identity areas, Child focus, Christian identity and community baseness are effectively integrated in DME practices through the TD philosophy and the DPA approaches
Undertake or update ICD and NO capacity building strategy
Work and influence to resource the strategy
Ensure the strategy is implemented and clear progress milestones are achieved towards making the NO teams equipped to deliver quality evidence
Assess NOs capacity, staffing levels for portfolio, skills mixes of the teams and advise leadership on a path to build strong teams
Develop staff motivation - Development and retention concept and engage with the SLT for resourcing and support
Engage the Senior Leadership Teams (SLTs) with M&E products and the QA teams to encourage progresses made and provide feedback for improvements as well as utilise M&E to inform key decision making
Engage the SLTs for adequate resourcing of QA at all years including capacity building
Support the two NO QA leads in strong PST engagement and influence the outcomes of PST engagements
Master’s degree preferably in a social science field
5 years minimum experience in M&E systems design including applications of technology in M&E processes and knowledge management processes and social research
At least 5 years’ experience in relief and development work, out of which at least two years must be in grassroots relief and development work in Africa
Commitment to and understanding of integrated ministry among the world’s poorest of the poor and well-being of children
Commitment to WVI.’s Mission and Core Values
Quantitative and qualitative data analysis with a known software such as SPSS
Working with mobile devices and online survey management tools
Skills in data analysis using computer programs and experience in design and facilitation of training programmes
Excellent presentation and communication skills with knowledge of various technical sectors of development such as food security, primary health care, micro enterprises development, etc
Commitment to life-long learning and must be self-motivated to achieve quality results and service
Motivated to work effectively in a collaborative team environment and demonstrate competencies in design and implementation of M&E plans at the project and programme levels including the accompanying MIS
World Vision Quality Assurance experience is preferred

Senior Director, Research Quality Assurance Resume Examples & Samples

Directs the strategic direction for the RQA function including GCP,
BA/BS required in a science-related discipline
The incumbent will have at least 10 years of experience in GCP, GLP and GVP roles in FDA-regulated biotechnology, pharmaceutical or medical device companies. At least 5 years of leadership of a team responsible for GCP/GLP/GVP compliance
Experience managing cross-culturally and/or globally is preferred
Experience working with CROs under a strategic partnership relationship is preferred
Previous experience in conducting GCP, GLP and/or GVP audits is required
Comprehensive knowledge of international regulatory requirements and guidelines governing GCP,GLP and GVP
Must be a hands-on technical professional when required
Demonstrated ability to lead and manage Regulatory Inspections
Strong oral as well as written communication skills
Ability to travel approximately 20% on average, including trips

Regional Director of Quality Assurance Resume Examples & Samples

Creates and maintains a strong partnership with senior sales executives, site vice presidents (VPs) and QA team members to meet and/or exceed sales retention and compliance goals
Executes and monitors all QA standard operating practices (SOPs)
Leads QA teams within business unit to meet and/or exceed all sales targets, retention and goals
Hires, trains and evaluates QA managers and team members to successfully perform all assigned tasks
Visits sites to monitor and evaluate performance
Reviews and analyzes regional and site rescission reports
Collaborates with Sales and QA teams to maintain and/or enhance site retention targets
Partners with Sales to develop action plans to improve sales performance when below target retention rates
Recommends Sales and QA recognition acknowledgements
Assists Sales and QA team members to resolve customer complaints with satisfactory results
Conducts performance reviews for effective program results
Observes closings to assess policy and standards adherence
Creates action plans as needed to improve performance
Ensures Sales and QA actions are compliant with company and department standards
Reports Sales process integrity violations to senior management immediately and provides solutions
Provides progress reports to management in a timely manner
A minimum two (2) years of experience in the vacation ownership and/or quality assurance field required
A minimum two (2) years of supervisory experience in the vacation ownership field required
Ability to drive results
Ability to motivate team members
Ability to train and coach effectively
Understands how to develop and implement business strategies
Proficient in time management; the ability to organize and manage multiple priorities

Director of Quality Assurance Data Security Products Resume Examples & Samples

Leadership: Must be able to lead, motivate and mentor a team of about thirty-five (and growing) quality assurance & test automation engineers. Must collaborate and interact well in a cross-functional team setting as well as work closely with peer product teams
“Hands on” – Must be willing to roll up the sleeves and gain a deep understanding of how the products work and be able to leverage that knowledge to give guidance to the team
Communication skills: Must have excellent written, verbal and presentation skills. Must be able to articulate and present ideas concisely and clearly
Ability to push back or hold ground whenever quality of the product should trump the schedule
Culture of startup balanced with the needs of a large enterprise SW: Must be able to innovate in QA methodologies for white box/black box testing, driving efficiency through test automation and test driven development
Engage & interact with customers and OEMs on discussions related to quality and security as it relates to Data Security products
Prior experience as a director or senior director of Quality Assurance at a well recognized enterprise security software/systems company and bringing well recognized products to market
Providing quality assurance for data and systems oriented products such as file systems/clustered file systems, volume managers designed to support legacy databases such as Oracle, DB2 etc. as well as the newer generation NoSQL databases such as MongoDB, Cassandra etc
Domain expertise in test case management, automation and testing for very large & complex ecosystems
Knowledge of test automation frameworks such as Selenium and ROBOT
Strong knowledge of NAS and protocols such as NFS and CIFS
Strong experience working at system level areas such as networking, security, databases, clustering and performance
Experience with testing products that use secure communication protocols such as OpenSSL, TLS, JCA/JCE, PKCS, KMIP etc. to provide data security
Track record of leading and managing high performance quality assurance teams in a geographically distributed setting
Strong network and reputation within the enterprise software and systems community
Managing geographically distributed teams
BS in Computer Science (MS Preferred)

Director of Quality Assurance Resume Examples & Samples

FDA regulated environment: 5 years
CGMP: 5 years
ISO 13485: 5 years
Quality Engineer: 5 years
CAPA systems management: 5 years

Senior Director of Quality Assurance Resume Examples & Samples

Identifies and resolves problems in a timely manner; develops alternative solutions; works well in a group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in decision-making process
CAPA
Compliance
Document & Data Control
Internal / External Quality Audit
Quality Control, Product Release
Management Review
Quality Inspections
Real Time Aging
Field Assurance
Assigned Quality System Management Representative for client: primary regulatory agency and customer contact on all quality related queries globally e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements
Instrumental in setting strategy to enhance and maintain Global Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, and global markets served e.g. US, South America, Canada, EMEA, APAC, CSR (Customer Specific Requirements)
At least ten years of work related experience, of which a minimum of four years' experience in a related management role
General knowledge of the medical device industry

Quality Assurance Director Resume Examples & Samples

Develops and implements quality planning, inspection methods and defect prevention/corrective action processes for new and existing products
Directs and oversees the work of quality professionals supporting manufacturing and design assurance
Fosters employee development to prepare others to assume increased levels of responsibility
Manages Expiration dating inquiries and reprocessing systems
Demonstrated ability to achieve productivity goals without sacrificing quality in a manufacturing environment
Full working knowledge and experience with all development procedures and processes, including design control processes
Must be able to maintain confidentiality of information when required
Must be able to work with all levels of employees in a matrixed environment, including hourly production employees through senior management

Director, External Quality Assurance Resume Examples & Samples

Minimum of 10 years Industry experience
Previous or current supervisory / management experience
Previous experience in Sterile Manufacturing, (in either Tech Ops, Mfg or Quality), people management, Regulatory Inspections, and in managing significant investigations is required

Director Business Analysis & Quality Assurance Resume Examples & Samples

Directs and controls the activities of a functional IT area through one or more department managers within the company. Including strategic planning & goal setting to set the strategic direction of the group
Business Analysis planning, tracking and control - accountable for the planning and execution of IT Business Analysis efforts, ensuring projects and change requests are completed on time and BA processes are followed
Quality Assurance planning, tracking and control – accountable for the planning and execution of the IT Quality Assurance efforts, ensuring projects and change requests are completed on time and QA processes are followed
Overseeing the development and implementation of IT related training programs and documentation efforts. Responsible for ensuring the appropriate training and documentation needs are being met
Collaboration with other departments and management as necessary
Evaluating data, developing recommendations, gathering and organizing information and developing presentation materials for management reviews
Understanding GAF’s applications and the interdependencies with other corporate and external systems and gaining comprehensive and extensive knowledge of business processes, issues and data challenges
Overseeing the review process for business requirements, functional requirements use cases, workflow diagrams, interface designs, test plans, test scenarios, test cases etc
Leverage experience to recommend industry standard and best practice solutions
Fostering and ensuring collaboration with various IT teams to coordinate system changes and to ensure appropriate system testing
Facilitating meetings and monitoring action items
Providing guidance and leadership to the Business Analysis and Quality Assurance teams coaching, mentoring, reviewing work, setting schedules, etc. and supporting resources as they develop and maintain relationships with business leaders
Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems
Recruiting, motivating and developing a superior staff. Effectively managing a team that is customer focused, encouraging creativity, driving performance, and effectively developing and rewarding key performers
Defines, develops, and implements, along with IT management, department-wide strategic plans and objectives
Helps business operations utilize information systems to improve efficiency
Works with managers to guide the overall direction, strategy, and management of the group, its processes and portfolio of work
Regularly interacting with senior management, customers, vendors and industry consultants to define service and performance levels in order to improve customer satisfaction
Responsible for education on business analysis and quality assurance standards and assuring process compliance
60%
15%Communication and Collaboration – regular communication with regards to BA / QA / D&T issues, project status, and many other various topics. Creating miscellaneous presentations, metrics reports, process documentation, etc. Regular communication with the business. Facilitating weekly team meetings and collaborating with team members across IT and the business
20%Development and institutionalization of Business Analysis, Quality Assurance and Documentation & Training methodologies, polices, procedures and metrics; manage and track; education, and process compliance
5% Perform other duties as assigned
Advanced knowledge of and development / execution of IT Standards, Policies and Procedures
Intermediate knowledge of Emerging Technologies
Advanced knowledge of and development, review, and execution of SDLC
Intermediate knowledge of Information Security Awareness
Intermediate knowledge of General Project Management Methodology & Tools
Intermediate knowledge of GAF Systems, Applications, & Technologies
Intermediate knowledge of Application Design and Architecture
Very Strong knowledge of Business Analysis Best Practices, processes and methodologies
Strong Understanding of modeling capabilities to document use cases / test scenarios, data, processes and events
Strong Experience in providing guidance in the development of and reviewing BA defined deliverables e.g. Functional Requirements Documents, Business Requirement Documents, Use Cases, Swim Lanes, UI Design, etc
Advanced knowledge across functional areas – HR, Finance, Supply Chain, etc
Very Strong experience in business process design and re-engineering and workflow analysis
Strong understanding of basic web and client / server architectures
Strong experience with ERP applications; PeopleSoft preferred
Strong knowledge of QA Best Practices, processes and testing methodologies
Strong Understanding of Application, System, End to End and Regression Testing
Strong knowledge of System Testing tools; tracking within testing tool - test case documentation, execution status and defect reporting
Strong Experience in providing guidance in the development of and reviewing QA defined deliverables e.g. Test Plan, Test Scenarios and Test Cases
Strong experience in translating functional and non-functional requirements into test scenarios and test cases that align with business processes
Excellent ability to Multi Task
Very Strong Prioritization skills
Very Strong Analysis & Problem Solving Skills
Very Strong Adaptability
Very Strong Vendor Management Skills
Strong Budget Management Skills
Very Strong ability to develop new policies, procedures and processes to improve the operations of the team
Very Strong Time Management Skills
Excellent Drive for Results
Excellent Ability to Think Conceptually and Forward Thinking All of the Time
Excellent Ability to Influence and Drive Cross Functional Decisions and Initiatives
Highly motivated self-starter
Very Strong understanding of dependencies within an IT Organization
Strong credibility with management and IT team
Advanced general business knowledge
Demonstrated ability to oversee and provide direction to team members involved in projects covering multi-disciplines, ensuring quality and timeliness of BA / QA / D&T team deliverables
Master’s or Bachelor’s Degree in Computer Science, Information Systems, or other related field
12+ years of IT and business/industry work experience
9+ years of leadership, management and supervisory work experience

Director, Global Design Quality Assurance Resume Examples & Samples

Leads and manages all MS, LC, Chemistry and other applicable Global Design Quality Assurance responsibilities including the meeting of local design quality activities and initiatives
Manages Global Design Quality Assurance teams and employees and ensures all quality requirements and processes are incorporated into product development and sustaining product improvement processes
Development, implementation and monitoring of policies and procedures to ensure the highest levels of product quality, design quality and customer satisfaction while maintaining regulatory compliance
Leads the design quality assurance initiatives, provides direction and leadership, and ensures that company objectives and regulatory requirements are met
Engages, leads and collaborates with the development and sustaining teams in deploying new, or changes to existing, processes and systems to improve the overall effectiveness, efficiency and compliance of the Quality system in accordance with, but not limited to, the requirements of ISO 13485, EU IVDD, new IVDR, and regulatory requirements including 21 CFR 820, 93/42/EEC and 98/79/EC as applicable
Actively participates in the product development process and ensures best-in-class practices and scientific analyses are employed
Be an active contributor and knowledgeable, contributing member and represent Design Quality on all projects
Drives product risk management activities and leads mitigation assessments and implementation in compliance with ISO 14971
Supports usability engineering activities in compliance with ISO 62366
Works cross functionally and within Waters Global Quality to ensure activities and potential improvement work is aligned, harmonized and standardized
Ensures information relating to product quality and the quality system is communicated to relevant management and staff within Waters
Implementation of corrective and preventive actions to ensure compliance of the quality management system with applicable quality and regulatory standards
Participates and supports audit activities, both internal and external
Produces, tracks and trends quality metrics to deliver tangible improvements to the overall business
Manages department budgets and meets them
Leads and/or participates in other projects as assigned
Minimum of a Bachelor’s degree required
Advanced degree is preferred (in a life science or engineering discipline; PhD, M.S., MBA or equivalent)
Professional certification is strongly desired (e.g. ASQ certifications)
Minimum of 5 years in managing employees
Minimum of 7 years of experience leading Design Quality function within a disciplined industry such as medical device, pharma, Biotechnology, life sciences or similar discipline arena
Proven quality leadership in the design and execution of quality systems compliant to ISO 13485, 21 CFR 820, ISO 14971 and ISO 62366
Design Quality Assurance - Has an excellent technical proficiency in the knowledge of regulatory requirements and standards which impact the design, development and manufacture of products
Demonstrated capability of managing design quality assurance and product development activities and objectives to plan
Experience with Class I/II/III medical devices/systems and/or in-vitro diagnostics (IVD) experience is highly desired
Prior experience in a leadership role with overall responsibility for directing a Quality organization is required
Able to work effectively globally
S/he must have a strong understanding of design control and design quality requirements
S/he will have the ability to identify and analyze complex problems and recommend actions
This position will develop schedules, budgets and have a comprehensive understanding of business objectives
Able to effectively manage teams and projects/programs
S/he will have proven track record in a matrix environment, exceptional team building skills and demonstrated ability to direct activities from concept through to completion
Outstanding Work Ethic
Effective communication and influencing skills
High energy problem solver/achiever – Self Starter
Well-Organized and Detail-Oriented
Strong team orientation and team builder
Ability to mentor and development members of the team
Successful History of Achievement
Experienced International Business traveler
Business financial analytics experience
Demonstrate sound judgment/rationale

Director of Quality Assurance Resume Examples & Samples

Proven knowledge of FDA guidelines and GCP is required
Organizational and prioritizing capabilities
Computer skills with ability to use clinical trial databases, electronic data capture, MS Access or Excel
Resourceful with heightened analytical abilities and problem solving skills in a fast paced environment
Interpersonal skills, detailed-oriented and meticulous
7+ years of management and/or supervisory experience
7+ years of quality assurance experience in a clinical research environment (i.e. Sponsor, CRO, or large investigative site)
Understanding of investigative site research requirements
10+ years of global clinical research experience preferred

Director of Quality Assurance Resume Examples & Samples

Establishes quality and reliability standards by studying product and consumer requirements with other members of the Management Team, production operators, QA lab technicians, and engineering staff
Manages and maintains FSMA compliance
Establishes raw material standards in conjunction with the R&D Team to ensure product quality, consistency and performance. This is also in collaboration with the plant operation requirements. Working with suppliers to determining testing methods, procedures and testing equipment
Establishes and fine tunes in-process product inspection standards, manufacturing methods; developing testing methods and procedures
Establishes analytical standards for the disposition of finished product by developing evaluation tests, methods, and procedures
Establishes product quality documentation system by writing and updating quality assurance procedures and SOP's
Maintains product quality by enforcing quality assurance policies and procedures and government requirements and training methods
Prepares product and process quality reports and summarizing information and trends
Maintains quality assurance staff by recruiting, selecting, orienting, and training employees
Maintains quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results
Bachelor's degree in food science, microbiology, or other closely related field, or an equivalent combination of education and experience
10+ years' experience in food or beverage operations and/or quality assurance management. Experience managing a team of quality assurance technicians preferred
Management of a high volume of inventory throughout multiple sites
Computer skills and knowledge of state-of-the-art lab equipment
HACCP, ISO, SQF or other food safety certification required
Food safety audit experience desired
Must be able and willing to travel up to 50-80% of the year

Director of Quality Assurance Resume Examples & Samples

Develop and oversee an effective quality management system to continuously identify opportunities for improvement while maintaining adherence to contract driven key performance requirements
Develop and deliver quality management and quality assurance training for all employees engaged in quality and performance monitoring
Monitor and evaluate the effectiveness of all areas of project operations and reports quality issues to project and unit management
Schedule, coordinate and report on both internal and external audit functions of the quality management system
Schedule and coordinate all the quality and performance monitoring activities of QA staff across the project
Produce the quality assurance and performance reports as required by contract and project operations
Attend project management meetings
A Bachelor’s Degree from an accredited college or university in related field, equivalent experience considered in lieu of degree Master’s degree preferred

Director of Quality Assurance Resume Examples & Samples

As a part of the site management team, provides business leadership and technical quality expertise to the Operation
As part of the site management team, develops the appropriate plans to support and meet the Corporate, Franchise, Region and Site operating Goals and Objectives
Ensures compliance with FDA’s Quality System Regulations, ISO 13485:2003 Medical Device Directive, Canadian Medical Device Regulations, and other applicable industry standards
Performs the duties of Management Representative for the quality systems at Mentor Texas, as defined in the appropriate Quality Manuals
Acts as liaison with the quality system registrar, FDA and BSI Notified Body
Implements and directs the use of Quality Engineering principles, tools and techniques to develop and optimize systems and processes that are aligned with the overall Company strategy and mission, driving continuous quality improvement
Leads the Quality Assurance staff, works with team members to generate career development plans, and provides coaching to address technical and leadership challenges
Coordinates and leads the site’s quality assurance strategy and its execution to ensure the production of quality products consistent with specifications, established standards, and in compliance with regulatory and industry standards
Develops and manages the Quality Operations strategy, leading the alignment across Mentor sites
Provides guidance to the Quality Engineering function in regards to reliability engineering, design control, product and process improvement efforts and product specification development
Builds cross-functional support through influence and persuasion in order to facilitate continuous product and process improvement
Partners across sites to learn about, develop, and implement best practices
Leads continuous quality improvements throughout the entire life cycle of Mentor products, including providing input into new product design and development, optimizing manufacturing for commercialized products, providing input into continuous improvement plans for sourced components, and leading customer-driven quality improvement teams
Is technically competent to evaluate design control/product validation activities and data to ensure that design control/validation activities and data are appropriately implemented and utilized to support desired objections and conclusions
Develops performance objectives for the Quality function based upon corporate and plant quality objectives. Has both the authority and responsibility to assure these goals are attained. Prioritizes goals for the QA/QE function to achieve deadlines
Responsible for developing, managing and executing the Quality budget including Cost Improvement and Capital Investment projects
Monitors the key quality performance measures and the corrective action results. Responsible for the CAPA and Non-Conforming Product systems and reporting on the results to management with executive responsibility; recommending and initiating appropriate corrective action as appropriate
Oversees the internal audit program that complies with regulations, Mentor policies and measures the effectiveness of the quality system
Serves as the site management representative as defined in the quality System Regulation and ISO 13485:2003
Directly responsible for hosting all external audit such as Medical Device Single Audit Program and OCP
Oversees the development of all new product and line extension launches
Manages QA personnel and resource allocation to meet QA objectives at the Mentor TX site
Bachelor's degree in an applied technical discipline
Based on education and or experience be able to provide appropriate technical input and review of design control and validation activities
Minimum of ten years of experience in a regulated field, supporting Manufacturing, Quality, and/or Compliance
Experience in other J&J franchises or external businesses operating in a regulated field is preferable
Prior management experience required
Medical device manufacturing experience required

Senior Director of Quality Assurance Resume Examples & Samples

You'll build methods for quantifying and tracking quality, both at the product level and client site level
Research/recommend/implement automated, repeatable test strategies that utilize best practices
Develop standard test plans, scenarios, scripts, and test procedures that can be utilized by BSA's (or other project team members)
Develop methods for determining product readiness prior to releases
You'll document, track, and project-manage software defects, using our bug tracking system (Jira)
You will maintain experienced product knowledge, including our product's various configurations in order to effectively test scenarios
Build and implement load testing strategies; monitor and evaluate changes to the product's performance
You'll collaborate with Development, Implementation, and Operations teams to establish quality throughout the organization
You'll assist with the review of software documentation and release notes to ensure technical accuracy, compliance, and completeness
May perform other duties/responsibilities as needed or assigned

Director of Quality Assurance Resume Examples & Samples

Assist the Program Director in the development and maintenance of written training materials for ongoing use at the OCDI Jr
Behaviorally trained licensed Ph.D or Psy.D. with experience working with OCD patients, specifically providing exposure and response prevention treatment
2+ years of experience
Experience in supervision/training of trainees and program development
All employees must possess basic computer skills to use a variety of electronic or online systems for communication, clinical and administrative purposes

JV Quality Assurance Director Resume Examples & Samples

Establish/Set Standards and Expectations for how we conduct Quality Assurance across all projects within the JV
Meet staffing requirements and resource sharing, as necessary, between the projects within the JV
Providing standardized reporting for the Quality Assurance functional area
Accountable for the performance of QA personnel on all the JV projects
Ownership of all quality programs for the JV (QA, QC, Audit, etc) which includes planning, establishing, documenting, and maintaining the quality assurance program
For providing indoctrination and training of project staff and management as defined in the PQAP
Minimum 10 years’ experience in Quality Assurance, minimum 5 of which must have been on a project
Minimum 5 years’ experience in leadership/management role
Extensive familiarity with Quality Assurance Programs and processes
Bachelor’s Degree in Engineering, Physical Science, or related field
Certification(s) in: Quality Engineer (CQE), Quality Auditor (CQA), and/or ISO-9000 Auditor
Experience in developing and/or managing audit systems
Fiscal responsibility as required by the Joint Venture agreement
Customers, suppliers, JV Partners
Project Managers, project personnel, estimating personnel
Trades personnel, union business agents
Various work locations in both field and office
Travel as necessary

Director, Post-marketing Quality Assurance Resume Examples & Samples

Establish annual master audit plan based on prior risk assessment to define audit need and periodicity of local vendor audits
Manage and oversee all local vendor GxP audits and assessments, including but not limited to PV, REMS, GMP audits at Specialty Pharmacies, inpatient pharmacies, as well as REMS related data/IT vendor audits
Ensure business functions timely notify plans to outsource GxP activities in order to duly perform assessment and selection of new vendors/business partners
Assess and select contractors conducting audits on behalf of Actelion SSF and act as their contract giver
Ensure proper root cause analysis / CAPA follow-up of audit findings, involving relevant business units
Act as host to Global Quality Management (GQM) internal audits and license partner audits conducted at SSF and coordinate corresponding CAPAs with CAPA owners

Quality Assurance Director Resume Examples & Samples

Organizes, directs, manages, and coordinates various departments, programs, and services related to managing resources, assuring quality services, and managing cases
Collects, analyzes, and manages real-time performance improvement data
Coordinates activities and acts as liaison with Professional Review Organization (PRO)
Reviews and recommends contracts with PRO, insurance companies, and managed care organizations
Designs and implements program evaluations of all aspects of resource and quality management
Develops cooperative relationships with other hospitals and community agencies to pursue goals related to case management, utilization review, and quality care
Designs and reviews policies and procedures related to quality management such as methods of data collection, outcome performance measures, chart review procedures, case analysis methods, and critical pathways analysis
Provides consultation, feedback, and recommendations to service providers and staff on resource utilization and adherence to quality standards
Responds to inquiries related to quality and resource management issues from customers, staff, compliance agencies, and others
Directs and/or conducts appropriate research into methods to improve utilization of hospital and medical resources and methods to improve patient care
Compiles statistical data and writes narrative reports summarizing quality management findings
Directs review of patient records to determine need for admission and continued stay in hospital
Directs personnel engaged in quality assurance review of medical records
Involvement in planning, developing, implementing and directing Nursing Services, to work collaboratively, with other interdisciplinary members which include physical therapy, social services, activities, dietary and other administrative and business staff. Other duties may be assigned

Director of Quality Assurance Resume Examples & Samples

Bachelor’s degree. Engineering or Business Management preferred. Master’s Degree preferred
10+ years of Manufacturing and Quality Assurance experience in Aerospace or other complex manufacturing industry with exacting/demanding requirements
AS9100 QMS knowledge and experience preferred
Demonstrated success at delivering superior business results through the effective execution of the Quality Management System
A solid compliance and regulatory background, including the administration of a Quality Management System
Possess Lean Manufacturing and / or Lean 6 Sigma skills and experience
Familiarity with advanced quality processes preferred, e.g. - PPAP/ APQP/PFMEA/8D or A3 problem solving
Overall knowledge, skills, and attributes reflecting: Leadership, Strategy Development, Financial Acumen, Negotiation Skills, Organization Skills, Communication Skills, Team Work, Creativity, and Visionary Forward Thinking
Accomplished in building positive relationships with co-workers, suppliers and customers

Director, Clinical Quality Assurance Resume Examples & Samples

Provides direction to the Clinical Quality Assurance (CQA) Operations and Systems Functions to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required to maintain compliance to applicable regulations
Responsible for ensuring that a strategic audit plan is designed and implemented for the development of all company programs, and that the activities are conducted and reports written according to SOPs and regulations
Represents the company and may serve as Inspection Administrator during regulatory inspections, both internally and externally, and provides strategic organizational direction to assure that responses are timely and appropriate to maintain the company’s good standing with regulatory agencies
Oversees all GCP and GLP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity
Establishes and leads and/or provides strategic direction to cross functional working groups to identify and mitigate GCP/GLP quality and compliance issues with potential impact across multiple programs, sites, or functional groups within the company including ROW sites
Determines acceptability of vendors for potential use and provides direction, guidance and strategy for company Quality
This position has overall responsibility for the ongoing development and operational success of the CQA function. This includes talent development and succession planning, resourcing and budgeting, and alignment of CQA initiatives, goals and activities with company goals
B.S. in Biology, Nursing, Pharmacy or related scientific field
Minimum of 10 years of increasingly responsibility in pharmaceutical, GCP-related Quality environment
Minimum 3+ years direct and indirect management level experience including senior level project planning/budget management
In-depth working knowledge of the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, FDA Regulations and Guidances and Computer System Validation
Auditing Knowledge: Understands the overall audit process including design, conduct and reporting, and corrective action follow-up
Communication skills: Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents
Project Management: Must be able to manage all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 25% travel
Science Knowledge: Possess the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states

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