Quality Director Resume Samples

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L Bernier

Logan

Bernier

5814 Paucek Creek

Philadelphia

+1 (555) 852 2040

5814 Paucek Creek

Philadelphia

Phone

p +1 (555) 852 2040

Experience Experience

New York, NY

Corporate Quality Director

New York, NY

Schmidt Inc

New York, NY

Corporate Quality Director

Assist Supply Chain Group in providing suppliers / SPG’s with vendor performance measures to facilitate recognition/corrective action
Create and implement Total Quality action systems that reflect customer-level performance
Develop and recommend corporate quality performance measures and standards
Develop, implement, and monitor safety training and performance in all districts
Work proactively to ensure safety awareness is created and actions are taken to eliminate hazards and risks
Review district quality performance measures on an on-going basis
Develop Corporate Quality vision

Houston, TX

Clinical Lab Quality Director

Houston, TX

Bradtke and Sons

Houston, TX

Clinical Lab Quality Director

To provide leadership for LabCorp quality programs including the implementation of policies and systems which lead to continuous quality improvement,
Providing and ensuring training and support for LabCorp quality policies and procedures,
Facilitating the maintenance of the Quality Management System (QMS) and associated policies and procedures,
Holding regularly scheduled Quality meetings/conference calls
Ensuring regular communication by
Responding to quality issues
Monitoring and responding to issues related to non-conforming events, quality indicators and other quality issues identified,

present

Philadelphia, PA

Quality Director, Data Integrity Leader

Philadelphia, PA

Waelchi, Herzog and Wiegand

present

Philadelphia, PA

Quality Director, Data Integrity Leader

present

Provides reports and analysis regarding DI program to Senior Management
Provides continuous, on going, and annual training to ensure awareness and compliance for DI Compliance Officers and the Patheon organization
Creates and/or updates Corporate Standards and procedures as necessary
Develops and reports metrics and KPIs to monitor DI program
Assesses technical responses to questions & issues raised by regulatory agencies and customers
Direct immediate reports and DI Governance team in setting priorities and project assignments
Serves as an advisor to Manufacturing & Quality Operations for DI matters

Education Education

Bachelor’s Degree in Health Care Administration

Pepperdine University

Bachelor’s Degree in Health Care Administration

Skills Skills

Certified Quality Engineer is
Proficient in Microsoft Word, Excel, Access and Power Point
Ability to speak effectively and present before groups within the organization
Ability to review and evaluate technical documents and determine impact to processes and systems in place
Ability to effectively present information and respond to questions from peers, management, suppliers and customers
Ability to review and write protocols, reports, and procedure manuals
Ability to solve problems with minimal guidance
Motivated, self-started, team player

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15 Quality Director resume templates

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HR Customer Service Quality Director Resume Examples & Samples

Set customer service and quality standards for delivery of HR services to ensure a seamless experience for the customer
Develop quality management plans by analyzing data / trends, identifying critical control points and preventive measures. Monitor procedures and drive implementation of corrective actions
Partner across the organisation to establish / review procedures, standards, systems and processes that enhance the HR customer experience
Leverage Six Sigma practices to enhance quality management
Determine training needs and recommend training solutions, to deliver high standard of customer service
Continuously enhance metrics and processes for measuring quality for customer interactions across HR

Ccb-risk-data Quality Director Resume Examples & Samples

Establishing a data quality methodology documenting a repeatable set of processes for determining, investigating and resolving data quality issues, establishing an on-going process for maintaining quality data, and defining data quality audit procedures
Collaborating directly with the business data owners to establish the critical sets of data that will require data quality rules and developing a plan and process for rule implementation
Working closely with data quality technical staff, applications developers, and the data owners/subject matter experts from the businesses to advance Risk’s objectives
Developing metrics and reporting to track the ongoing quality trends across a variety of data quality dimensions; analyzing metrics and utilizing them to prioritize areas for data quality improvement
Working collaboratively with CCB Risk process owners, Technology, and CCB Data Management to facilitate the development and evaluation of business readiness for data quality processes
Providing clear leadership to staff, based on understanding of business issues and senior management guidance, and proactively determining new approaches as the needs of the business change
7+ years experience in Risk data analytics, data management, or data quality at a large firm
Master's degree in a quantitative field such as Finance, Economics, Statistics, Mathematics, Computer Science, or equivalent business experience
Strong knowledge of database and data modeling concepts; expertise in data usage in management reporting, modeling, or analytics
Expertise in applying data quality rules and data quality monitoring across complex data environments
Strong organizational skills and a proven track record in delivering complex projects across multiple lines of businesses or functional groups
Ability to navigate well and partner with various functional area leaders to identify key dependencies and deliver results
Ability to manage issues to timely resolution in support of project execution
Experience in managing staff in multiple locations
Strong knowledge of consumer businesses as well as key compliance, regulatory & control, IT risk, legal and risk operational requirements and challenges

Regional Business Quality Director Resume Examples & Samples

Provides region-wide leadership for implementing and continuously improving quality, Quality Management Systems and compliance (40%)
Represents JJVC to other J&J departments (e.g. ERC), external audiences for audits, registrations, and local regulators and Health Authorities (40%)
Communicates to all levels of the organization (10%)
Performs other related duties as assigned by management (10%)
Minimum education required for competent performance
Bachelors Degree - Technical
Advanced Technical Training in DOE, Statistics
Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance
15+ years working experience in technical / quality / regulatory role in the Medical Device Industry
Ability to travel up to 50% required
Excellent project management skills required
Excellent problem solving skills required
Excellent communication, interpersonal and organizational skills required
Excellent understanding and application of principles, concepts and practices of statistical methods preferred
Strong leadership, coaching skills required
Demonstrated management abilities required
Thorough understanding of regulatory / compliance requirements for specific region
Equipment usage and abilities needed: Personal Computer, Printer, Telephone, Facsimile, Copier, Calculator, Microsoft Office products, Software as required
Conditions & Physical Demands of Job: Walking, Hearing, Talking, Keyboarding, Inside Environmental Conditions, Other
Ability to travel 50% of the time

Cpai / Quality Director Resume Examples & Samples

Responsible for oversight and assessment of clinical performance data and care delivery practices. Collaborates with administrators, physicians, clinical leaders and staff to identify improvement opportunities utilizing quantitative techniques, knowledge of health care operations and systems thinking. Obtains and uses literature, evidence-based practice and benchmark data whenever possible
Improves clinical performance: identifies causes of variation, serves as a subject matter expert and supports implementation of systems and processes to facilitate effective clinical practice. Leverages results from Peer Review, Regulatory, Patient Safety and others to align performance improvement opportunities with system and local teams
Facilitates prioritization of improvement activities with system and entity leadership. Conducts in- depth assessment of qualitative and quantitative data. Triangulates information to support administrative and clinical decision making. Collaborates with the appropriate process owner(s) to identify opportunities for improvement
Establishes and oversees the development and implementation of annual quality plans with administrative, service line and process owners. Strategizes with entity leadership to plan and coordinate local Quality Councils
Manages and coaches performance improvement activities and oversees projects in collaboration with project leaders and administrators. Serves as a resource and/or facilitates improvement teams to plan, implement, and coordinate entity activities to maximize clinical and operational outcomes. Participates on improvement teams, guiding teams on system defined improvement methodologies and processes
Maintains clinical performance assessment, performance improvement, change management and project facilitation expertise through independent study, internal development courses, attending education workshops, reviewing professional publications, establishing personal networks, and participating in professional organizations
In some settings, responsible for recruiting, selecting, developing, mentoring, supervision and assessment of staff. Also responsible for creating and managing departmental budgets

CMO Quality Director Resume Examples & Samples

Provide leadership in the implementation and oversight of the Contract Manufacturing Organization Quality Program
Provide global oversight of contract activities and ensure compliant services for Sanofi Pasteur
Ensure corporate priorities and strategies as deployed taking into account SP site’s needs
Ensure robust processes are in place globally and on sites to deliver according to plan
Responsible for independent compliance assessment of Contract Manufacturing Organizations
Ensure that campaign reports are appropriately managed and used to define the following year’s improvement action plans
Lead Global initiatives for improvement of compliance activities
Represent Sanofi Pasteur in different governances associated to the management of external services
A Bachelors's degree in a scientific field; Biology, Pharmacy and Microbiology would be preferred
Twelve years direct experience in pharma/biotech manufacturing and quality environments/organizations with at least 8 years pertinent experience in Quality
A strong knowledge and proven expertise in compliance
High level of autonomy and independence
Must be a good communicator
Contributes to and support performance and continuous improvement

Quality Director Home Health Hospice Resume Examples & Samples

Determines strategy for changing existing processes to meet regulatory requirements & translating external demands into program goals
Consults on performance review methodologies & performance improvement teams
Collaborates w/supv in implementing regional/agency/organizational goals & objectives
Develops & maintains relationships & effective communication w/all levels of physicians & staff in order to facilitate problem identification & resolution
Effectively communicates both verbally & in writing to assure that the staff, leadership & Quality teams are informed of the status & issues related to the Performance Improvement program, utilization Mgmt & risk Mgmt
Negotiates organizational barriers for employees & ensures that necessary resources are available & accessible
Works closely w/Dirs to address patient care issues w/a goal toward resolution while maintaining confidentiality
Oversees Quality Improvement & prepares quarterly reports for the hospital to the KP Board of Dirs
Manages dept staff
Makes recommendations regarding the need for staff, space & other resources
Instills a sense of customer focus in employees/volunteers
Holds self & others to high standards of performance, & is accountable for results achieved & not achieved
Supervises work of other Quality dept staff
Provides quality oversight of both internal & external contracts
Minimum three (3) years of experience in Quality Improvement in a health care setting
Clinical nursing experience preferred
Management/operations experience in Home Health or Hospice

Quality Director Resume Examples & Samples

Lead Quality reviews and cockpits, including development of standard protocols, schedules, KPI’s with focus on process integrity & product conformance, and communication of quality performance to all employees
Lead & make step function improvements in First pass yield, cost of poor quality, internal non-conformance cost & reduce warranty
Manage and optimize the Corrective/Preventive Action programs/systems (CAPA) to effectively resolve product/process deficiencies through the use of proven problem-solving tools & techniques, including the verification of effectiveness/sustainability of measures
Train, develop, and empower the Quality Engineering team while ensuring consistent proficiency and approach toward process improvements aimed at product integrity through the enforcement of applicable quality standards
Define and implement a process & product audit program, including activities around documenting deficiencies, corrective actions and subsequent verification of effectiveness. Includes training stakeholders to drive ownership & accountability
Lead & support internal auditing in addition to any Quality certifications
Drive measurable change in product/process quality through the development, implementation, and enforcement and monitoring of the accountabilities listed above
Support central quality management (QPI) as liaison between Quality Management and Gas turbine manufacturing
Manage all NDE (MT / PT / ET / RT / UT / VT) activities, from the establishment of training protocols (Theoretical & Practical) that satisfy external certification requirements to the management of personal recertification needs
Ensure work in accordance with approved standards, policies, procedures and quality plans. Ensure inspections comply with applicable industry standards
Drive measurable change in product/process quality through development, implementation, enforcement and monitoring of the accountabilities listed above
Bachelor’s Degree in Engineering or equivalent, preferably Mechanical, Manufacturing, or Industrial Engineering background
Minimum of 8 years of experience in heavy industry, with at least 7 years of experience in Quality-Management and/or Continuous Improvement with a focus on Process Development/Qualification/Optimization/Problem-Solving
Experience in managing employees desired
Experience in the power generation industry is an asset
Demonstrated leadership in APQP, problem solving and root cause methodology, FMEA, corrective action and improvement processes
Experience in auditing with knowledge of ISO 9001 Quality System
Ability to effectively communicate & collaborate with customers and employees at all levels
Competency in Microsoft Office Suite required
Competency in SAP and SAP Quality Management desired
Required travel for position expected to be less than 20 %

Quality Director, Compliance Resume Examples & Samples

Bachelor’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 QA
Experience working with customers – Contract manufacturing experience preferred
Proven ability to multi-task and demonstrate diplomatic skills
Must possess excellent English verbal and written communication skills
Intermediate to proficient skills in Microsoft Office applications
Prior quality assurance experience is required
Working knowledge of cGMPs and/or OSHA regulations required. Prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.) and additional disciplines (e.g. DEA)
Certified Quality Engineer is a plus
Excellent oral and written communication skills a must
Proficient in Microsoft Word, Excel, Access and Power Point
Ability to speak effectively and present before groups within the organization
Ability to review and evaluate technical documents and determine impact to processes and systems in place
Ability to solve problems with minimal guidance
Ability to review and write protocols, reports, and procedure manuals
Ability to effectively present information and respond to questions from peers, management, suppliers and customers
Motivated, self-started, team player

Quality Director, Commercial Operations Resume Examples & Samples

Bachelor’s Degree in Science (Chemistry, Microbiology or Biology preferred) preferred however relevant years of experience will be considered
A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in QA
Experience working with customers – Contract manufacturing experience preferred
Prior experience working with customers preferred
Proven ability to multi-task and demonstrate diplomatic skills
Must possess excellent English verbal and written communication skills
Intermediate to proficient skills in Microsoft Office applications
Prior quality assurance experience is required
Prior validation experience is required
Working knowledge of cGMPs and/or OSHA regulations required. Prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
Certified Quality Engineer is a plus
Excellent oral and written communication skills a must
Proficient in Microsoft Word, Excel, Access and Power Point
Ability to speak effectively and present before groups within the organization
Ability to review and evaluate technical documents and determine impact to processes and systems in place
Ability to solve problems with minimal guidance
Ability to review and write protocols, reports, and procedure manuals
Ability to effectively present information and respond to questions from peers, management, suppliers and customers
Motivated, self-started, team player

Outpatient Quality Director Resume Examples & Samples

Collaborates with other Service Directors / Chiefs of Service in identifying and implementing innovative models and best practices, emphasizing service improvements and cost reduction
Directs development and implementation of quality and utilization standards across the continuum of care to ensure coordinated plans of treatment, customer focused delivery of services and cost effective utilization of necessary services. Ensures compliance with administrative, legal and regulatory requirements of the Health Plan contract and governmental and accrediting agencies
Oversees the development of department standards as identified by regulatory agencies. Develops services that achieve a high level of customer satisfaction with emphasis on customer service, highest standards of quality and innovation. Manages and resolves human resource, labor relations, employee and department safety and risk management issues. May act as site administrator
Utilizes research data to implement clinical changes and the delivery of patient care and member services. Directs the budget and resource allocations. Manages the financial performance and identifies and implements strategies to reduce costs and improve quality of care and services
Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees
Minimum five (5) years of management/program leadership experience required
Minimum three (3) years of experience in an outpatient care setting
Master's degree preferred

Quality Director Injectables Resume Examples & Samples

Manage the US injectable manufacturers (Third Party Manufacturers, Affiliates, and in-house Operations) activities. The scope of the position encompasses oversight of all aspects of quality support, including Market Release, Regulatory Compliance, FDA Inspections, Market Complaints, Product Recalls and support for Product Development, Product Site Transfers and Product Launches for the Mylan US franchise
Maintain Quality Oversight of Contact Person for Vendors, Third Party Manufacturers (TPMs) and Affiliates to ensure Mylan interests are met and that relationships are properly maintained
Manage the Vendor, TPM Audit Program, Technical Agreements and Quality oversight of in-House Operations relating to the US market
Manage the review of executed batch records, analytical raw data, stability protocols, reports and other documents from the in-house operations to enable final drug product release and ongoing evaluation certifying batches as GMP compliant for the US market
Manage the Annual Reports, Annual Product Quality Reports, and Stability Program for TPMs and the in- house Operations
Manage Product Complaints prepare/follow up on escalations for TPMs, Affiliates, and in- house Operations, if required
Prepare/Review/Submit Initial FARs, Follow up FARs, Final FARs and submit Recall Documentation for (TPMs), Affiliates and in-house Operations, if required. Coordinate between the Field Office and Regulatory bodies for TPMs, Affiliates and in-house Operations, if required.#
Quality Support for Product Development, Site Transfers and Product Launches supporting commercial US operations for Third Party, Affiliates, and in-house Operations
Assist staff with their responsibilities establishing goals that will increase their knowledge and skills level
Bachelors Degree in Science or the equivalent
Proven Pharmaceutical experience
Must possess proven knowledge in a Quality Management role within the pharmaceutical sector
Experience in the area of Sterile Manufacturing is preferred
Previous leadership experience and experience with CMO management a distinct advantage
Ability to solve problems with complex variables through non-standardized solutions that require independent judgment and analysis
The experience and passion to contribute positively to the professional development of a high performing team is a must
Ability to travel
Proficiency in speaking, comprehending, reading and writing English is required

Clinical Lab Quality Director Resume Examples & Samples

Minimum 7 years’ experience with quality management responsibilities in a clinical lab
To assure the overall quality of services rendered to laboratory clients,
To act in a proactive manner in the identification and rapid resolution of problem issues which adversely affect LabCorp quality,
To provide leadership for LabCorp quality programs including the implementation of policies and systems which lead to continuous quality improvement,
To promote a culture of quality throughout the LabCorp laboratory system through communication and increased quality awareness
Assuring all laboratories within the division or area of responsibility maintain current federal, state and local licensure and accreditations, as applicable,
Providing interpretation of regulatory and accreditation requirements as well as guidance on meeting the requirements,
Assisting in formulating policies with respect to regulatory and accreditation requirements,
Facilitating the maintenance of the Quality Management System (QMS) and associated policies and procedures,
Providing and ensuring training and support for LabCorp quality policies and procedures,
As required, collating and presenting summary data for management reports including but not limited to analysis of potentially license-threatening deficiencies, adverse outcome of any agency inspection, audit or complaint,
Participating in and leading audits and inspections of the QMS, targeting identified problems and trends as needed,
Monitoring and responding to issues related to non-conforming events, quality indicators and other quality issues identified,
Facilitating process improvement and corrective actions and developing and monitoring effectiveness checks as required
Upon request, actively participating in the due diligence process for mergers and acquisition,
Serving as a liaison and resource in monitoring and responding to quality concerns,
Ensuring regular communication by
Holding regularly scheduled Quality meetings/conference calls
Responding to quality issues
Escalating quality concerns to the National Office of Quality, as appropriate
This job description reflects the essential functions of the position and excludes those that may be incidental to the performance of the job. In no way is it stated or implied that the principle functions are the only duties to be performed. Employees will be required to follow any other job-related instructions and to perform any other job related duties requested by their supervisor

Medical Affairs Quality Director Resume Examples & Samples

Minimum five (5) years of experience in a Quality role working with National Quality Stakeholder Organizations
Minimum five (5) years of experience as a Quality decision maker in the payer or integrated delivery system space
Thorough knowledge of quality and measurement, quality management, US health care delivery system structure and functions, population health management, care coordination/case management, value-based payment and health care delivery policy and trends
Strong track record of effective cross-functional team collaboration and execution
Excellent interpersonal communication skills, ability to network, strong personal integrity, collaborative mindset, and a strong customer focus are necessary
Must possess a thorough understanding of the FDA, OIG, HIPAA and other ethical guidelines relevant to the pharmaceutical industry
Engagement and recognized capabilities with National Quality Stakeholder Organizations

Quality Director Resume Examples & Samples

Directs and supervises quality staff and projects to meet unit goals for the quality program, including the monitoring of policies, procedures, activities, to meet multiple contractual requirements, external accreditation, and state and federal regulations
Ensures that studies and activities are conducted with appropriate feedback from customer organizations, assigned departments, and member and provider input
In consultation with assigned business unit leadership, sets priorities for improving operations based on data from performance indicators, delegation audits, and quality improvement processes
Serves as liaison with department managers to ensure that needs are met for internal and external reporting and analytics and the development of decision support tools
Oversees internal and external audit procedures to meet customer requirements, accreditation standards and goals of the assigned business unit
Serves as co-chair of the unit's Quality Improvement Committee and provides oversight of committee documentation
Assists Learning Department in development and presentation of CQI and compliance training programs for staff and customers

Retiree Solutions Quality Director Resume Examples & Samples

Provides day to day clinical account management support for assigned employer group account(s)
For assigned employer group account(s) is the liaison to the URS Client Management Team and the employer group account(s) for improving Star ratings, risk adjustment accuracy and medical cost reduction opportunities
Provides real time data informatics and clinical support to the Medical Director(s) for assigned employer group account(s)
Build strong relationships and partner with local market teams and internal clinical teams (Optum, HouseCalls, UnitedHealth Network, United Clinical Services UHC Medicare and Retirement and UHC Employer and Individual) to drive successful outcomes and improvement opportunities
Educate and partner with market teams on specific needs for URS business priorities
Participate in UHG market meetings to represent URS needs and look for opportunities to leverage or expand local market initiatives
Create monthly report highlighting employer group account specific performance and state performance; highlight recommendations for performance improvement and ensure initiatives are in place to achieve goals
Negotiate priority initiatives and strategies with senior business leader for the assigned state(s) and employer group(s)
Ensure all Star related activities within Alabama are achieving the desired 4+ star results
25-50% travel
Licensed Registered Nurse and able to obtain an Alabama license
5+ years clinical experience within the health care industry
5+ years of client management experience
5+ years interpreting complex data and making strategic recommendations
5+ years of experience driving quantifiable operational improvements
Must reside in Texas and willing to travel to Alabama 50%
Strong knowledge of Medicare Advantage Star Ratings
Demonstrated ability to interact with medical practices, peers, and internal company staff at all levels
Proficient with MS Outlook, Word, PowerPoint and advanced Excel skills
Strong knowledge of documentation and coding/risk adjustment accuracy
Care Management expertise
Project/program management experience

Product Quality Director Resume Examples & Samples

Leads a diverse team of Quality Engineers and professionals responsible for ensuring the quality of Juniper products shipped from Juniper’s Manufacturing partners
Collaborates cross functionally with Juniper teams to set Quality strategy and policy in Supply Chain Operations in support of Juniper’s Corporate strategies
Leader and Representative for Operations to internal and external customer and customer teams
Key leader for ensuring coordination of Supply Chain resources to support critical customer escalation
Responsible for driving continuous improvement on key process metrics related to the manufacturing including field performance metrics, manufacturing yield programs
Ensures success of critical quality related projects, programs, and quality initiatives
Collaborates with Juniper Supply Change Management team, manufacturing partners, and Juniper’s technical and Engineering teams to ensure quality outcomes throughout the product development and life cycle
Drives a high performance team through continuous mentoring and support of team skills and career development
Responsible for setting out programs that ensure continuous development and growth of quality team

Category Quality Director Respiratory Resume Examples & Samples

Develop and execute Quality Strategies that ensure identification and mitigation of key risks as well as provides rapid resolution to issues
Identify Quality resource needs to deliver Projects as well as ensure Quality resources execute and deliver project critical path milestones and launches
Bachelor’s Degree in Chemistry, Pharmacy, or other closely related areas, Masters or PhD preferred
Significant experience (10+ years) in the Pharmaceutical industry
Strong experience (5+ years) in Quality or Analytical for an OTC or Rx company
Cross-functional Quality experience in

Tax Practice Policy & Quality Director Resume Examples & Samples

Involvement in managing and setting the standards for how the TPQ practice operates
Responsible for developing a platform to grow the Tax Services Practice implementing best practices; work on substantive engagements, be involved in a broad variety of client issues and relationships, and work with tax professionals throughout the entire Firm, NTO, Legal, and PSG
Develop sensitivity and judgment on the legal, ethical, and business issues that make a strong professional practitioner and underlie the Firm's Guiding Principles
Assist in monitoring and developing the quality of Grant Thornton’s tax practices and compliance with regulatory requirements and best practices
Assist in the development and implementation of tax quality audit programs and professional training programs
Participate in Tax Practice policy development: client acceptance matters; tax opinion issues; tax shelter issues; engagement letter procedures and engagement management; and other matters bearing on risk management
Demonstrate and maintain technical expertise in matters related to Tax Practice Policy and Quality
Ensure continuous development of tax professionals
CPA and/or JD required; MT or LLM in Taxation preferred
Manager level tax experience; strong tax research skills; familiarity with Circular 230, AICPA Statements on Standards for Tax Services and other AICPA and professional guidelines and rules; Sarbanes-Oxley experience a plus
Demonstrated success in a leadership role and evidence of strong organizational management skills
Excellent analytical, organizational, writing, and project management skills
Some travel involved to meet with tax practices, relevant tax practice meetings

Quality Director, Data Integrity Leader Resume Examples & Samples

Responsible for the strategic leadership Data Integrity (DI) and Data Governance program, including defining policies, standards and procedures, establishing process and tools and working collaboratively with all Patheon sites to implement the data integrity program
Provides continuous, on going, and annual training to ensure awareness and compliance for DI Compliance Officers and the Patheon organization
Creates and/or updates Corporate Standards and procedures as necessary
Develops and reports metrics and KPIs to monitor DI program
Establishes company standards for equipment & computer systems to ensure compliance with DI requirements
Establishes and leads a Surveillance program to audit all GMP facilities within the site for compliance to establish documentation and DI standards, practices, and procedures
Direct immediate reports and DI Governance team in setting priorities and project assignments
Assesses technical responses to questions & issues raised by regulatory agencies and customers
Serves as an advisor to Manufacturing & Quality Operations for DI matters
Represents the company as a subject matter expert during regulatory and customer audits for DI
Collaborates on projects to meet customer, business, and regulatory requirements
Provides reports and analysis regarding DI program to Senior Management
Leads Corporate DI remediation efforts
Supports company integration activities with regards to DI
Is a member of the Global Quality Leadership team
Stays current on industry and Regulatory DI trends, communicates and adapts the program as necessary
15+ years experience in pharmaceutical, biologics or API manufacturing environment
10+ years experience leading a Data Integrity function within a pharmaceutical organization
Demonstrated leadership capabilities including working in a global environment and influencing without direct positional authority
SME on GMPs and specifically Data Integrity and Data Governance requirements
In depth knowledge of laboratory and or manufacturing equipment
Excellent verbal & written communication skills required to communicate at all levels of the organization (front-line to Executive Committee) required
Impeccable leadership, interpersonal skills, initiative, creativity and ability to work independently required
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint
Ability to work on multiple projects simultaneously utilizing well developed project management

Regional Quality Director, CCS Resume Examples & Samples

Act as a Quality Champion within the region supporting the development and cultivation of a Culture of Personal Quality within the organization
Oversee the approval of objectives, policies, and programs to support the CCS Business Unit Quality Strategy. Monitor metrics and direct activities to assure continuous progress towards achieving defined objectives
Ensure that the requirements and needs of the customer are clearly understood and defined. Coordinate the activities of all regional locations internal to the Business Unit, so that these needs are uniformly satisfied and that the source of the products or services is transparent to the customer
Direct the Business Unit’s Quality Programs and procedures to improve cost reduction and enhance efficiency
Provide the resources/training for the use and deployment of applicable quality tools within all levels and all groups of the organization to promote a strong Quality culture across the entire organization and to promote a fact-based decision making process
Develop and maintain effective Quality information systems that communicate key Quality related information and performance. Reports should be timely, thorough, and provide sufficient analysis or recommendations that appropriate actions may be taken. Establish and communicate minimum standards of product, process, and service levels for all locations in the region
Coach, mentor and lead highly dynamic team members to help achieve the requirements of this position as well as the individual career goals of team members
Working knowledge of ISO/TL 9000 Quality Management System Standards
5 years or more of previous Quality Management experience, preferably within a multi-plant manufacturing environment
Excellent communication and interpersonal skills. Ability to work effectively with all operational and functional areas and across international/cultural boundaries
Ability to drive change where required
Ability to manage mid-level managers at multiple locations, including sites around the world involving differing cultures, languages, and customs

Quality Director Home Health & Hospice Resume Examples & Samples

Works closely w/the medical, nursing, & support staff to ensure compliance
Provides edu & tech support to the agency in developing, implementing & maintaining quality improvement activities
Collaborates w/clients, TPMG, & community in designing processes that continually improve the quality & levels of care & the delivery of srv
Identifies & implements practices to improve quality & srv
Manages the creation & maintenance of provider-specific quality improvement profiles to be used for credentialing
Develops systems, templates & processes to identify & monitor indicators which best measure improvement in care delivery as well as credentialing & recredentialing of providers
Establishes mechanisms for proactive identification of issues & tracking of corrective action to min negative impact & max learning
Ensures that the agency's Performance Improvement Program is comprehensive & integrated, in compliance w/all licensing & regulatory requirements & consistent w/policies, procedures & standards
Participates in the development, implementation & evaluation of best practices for Home Care
Effectively creates & facilitates collaboration & cooperation among diverse grps, people, depts, & professional disciplines
Coordinates completion of annual evaluations & revisions to the Quality Improvement Program
Recognizes achievements of staff/volunteers through rewards, recognition, & public communication
KP conducts compensation reviews of positions on a routine basis. At any time, KP reserves the right to reevaluate & change job descriptions, or to change such positions from salaried to hrly pay status
Master's degree in nursing/administration/health related field preferred

Senior Quality Director Resume Examples & Samples

Responsible for organizational planning and design for the CVG returned Product Analysis, Complaints and Regulatory Reporting Teams to maximize effectiveness and efficiency while ensuring all Quality requirements are met
Creation of a high performance organization. Ensures that workloads are effectively prioritized and organized between teams and that talent is effectively selected, developed, retained, and engaged
Lead, coordinate and manage resources and direct reports to implement Quality plan deliverables
Leads the management, review, and reporting of teams, representing all Cardiac and Vascular Group businesses and sites establishing goals, objectives, and metrics for Returned Product Analysis, Complaints and Regulatory Reporting processes to meet business needs
Be an active member of Global Compliant handling sub council, defining, developing and executing GCH strategies and ensuring flow down to the CVG
Provides input to GCH system design and ongoing enhancements to meet Regulatory Reporting requirements
Responsible for ensuring that the Returned Product Analysis, Complaints and Regulatory Reporting processes and procedures are structured and maintained up to date to meet quality and regulatory requirements
Ensures that the team supports Regulatory Affairs by providing reports regarding Returned Product Analysis, Complaints and Regulatory Reporting to support regulatory submissions (PMA annual reports, etc. as required
Maintains working knowledge of current regulations and standards applicable to Medtronic CVG quality systems for drugs and devices, and combination products
Ensures that the team assists in any reporting issues that involve any product previously or currently marketed by Medtronic. This includes global products that have been handled by other facilities
Provides leadership to ensure that global Sales reps are trained in their obligations related to complaint reporting and product returns
Responsible for the operational functioning of the global team, such as planning and budgeting
Identify opportunities to eliminate waste, poor cycle times, inefficiencies, poor productivity and others to implement changes to PXM processes that will result in best practices and continuous improvement
Implement programs and process improvements ( e.g transactional COS) to align the CVG Quality strategy
Partner with BU QA function and leverage opportunities and work together to drive improvements and efficiencies
Work and partner closely with the Global QC and GCH sub council to ensure alignment on Quality strategy / Quality objectives and goals
Influence, lead, and coordinate cross-functional team of diverse stakeholders to deliver expected results on-time and on- budget
Develop, advocate and enable the MOS/COS tools and methodologies to drive process excellence
All activities must be performed in compliance with the Quality System
Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations
Travel requirement: minimum 10%-25%
Bachelor’s degree
15+ years of progressive leadership experience in driving continuous improvement
5+ years of Program Management experience
10+ years working in Quality environment
5+ years People Management experience
Master’s Degree
Experienced in Returned Product Analysis, Complaints and Regulatory Reporting arena
Lean or Six Sigma Training/Experience
Working knowledge of Vigilance & MDR filing regulations
Proven leader in the development and implementation of Quality strategies
Solid coaching and mentoring competency
Able to lead virtual team and be effective team
Ability to simply and clearly convey and communicate complex concepts
Continuous Improvement tool mastery
Competent at Excel, PowerPoint and Minitab (or other similar software)
Proven track record of driving continuous improvement and delivering results Strong analytical skills
Problems solving and decision making skills
Ability to effectively communicate at all levels and across the organization
Strong understanding of all business processes
Strong interpersonal, presentation, and project management skills
Computer literacy. Uses required computer hardware and software as productivity tools in performing work-related tasks - Word, Agile, Excel, Outlook
History of increasing responsibility

Customer Quality Director Resume Examples & Samples

Intimate knowledge of design and production methods of both seats complete (JIT) and frame production
Strong back ground in seat supply base commodities, product and processes
Capacity to communicate effectively with all levels of employees, management, engineers, as well customers
Ability to make decisions to support departments to ensure customer satisfaction is the end result
Per Salary Training Plan Matrix
4 years college degree, BA or BS preferred or technical equivalent
Extensive (5 - 10 years min.) knowledge in APQP planning, tracking and execution

Quality Director Resume Examples & Samples

Introduce a total quality management (TQM) environment through the integration of technical and production resources driving process ownership and accountability to their lowest attainable levels. Define individual functional responsibilities for optimal departmental performance and administer a broad based training program to ensure adequate skill levels are maintained and progressive growth and job satisfaction are attained
Provide hands-on leadership and technical direction to QA and QC departments in achieving department strategic, tactical, and quality goals
Create and implement robust Quality Management System to ensure State and Federal FDA, GMP and OTC compliance
Assist in the development of effective sampling plans and testing methods. Monitor the inspection and analytical testing practices for validity and safety
Strengthen quality assurance’s infra-structure through education, training, performance based appraisals, and recruiting. Establish and monitor specific individual goals and objectives
Monitor and communicate daily, weekly, and monthly quality performance results and appropriate key financial indicators
Assist in the development of department financial budgets. Define and closely monitor short and long term quality objectives in the areas of cost reduction, decreased inspection, decreased quality rejections, and increased quality awareness
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
Bachelors Degree in a scientific or engineering field; Masters degree is preferred
5- 10 years of experience in Quality department (OTC Cosmetics industry) with demonstrated ability to identify, define and implement quality systems
Solid knowledge of GMP systems as applied to ISO 22716 and OTC Cosmetics and drug products
Must have knowledge and Understanding of domestic & international regulations (FDA, TGA, HPB and ICH), guidelines and practices for cosmetics and OTC products
Ability to serve as primary host for FDA and/or notified bodies
Strong knowledge of analytical and microbiological methods and practices
Leadership Skill - Strong drive to deliver business goals and identifies new opportunities. Ensures long term success by creating objectives and committing resources to sustain the future of the organization
Management Skills - Demonstrated ability to set and communicate clear standards and expectations. Develops and supports an open environment where challenge is viewed positively. Aware of own impact and what drives and motivates others. Provides coaching and feedback to help employees perform at their best
Language Skills- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Reasoning Ability- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Computer Skills - Strong knowledge of Microsoft Office is required
Certificates, Licenses, Registrations - ASQ GMP certification, Quality Manager certification, and Quality auditor certification is a plus

IP Video Quality Director Resume Examples & Samples

Strategy
IP Video Technologist familiar with the technology and distribution methods of IP Video
Diplomat-skilled at handling difficult situations
Self-Managing-works with manager to identify goals and can handle without much need for clarification
Leader-Can lead a team of both direct reports as well as parallel, non-direct report team members for special projects, towards accomplishing an organizational goal
Technical operations project management experience
Strong communication and negotiation skills
Experience with Tableau and Splunk reporting a plus

Regional Quality Director Resume Examples & Samples

Develop and execute an innovative departmental budgets that will strategically leverage diverse resources, prioritize and support real time operation and long term productivity, quality and efficiency goals
Build strategic working relationships with peers in achieving and maintaining the accuracy and consistent flow of information, execution of procedures, and performance of the overall Quality Operations
Interact with vendors to ensure incoming quality of materials and components and lead investigations to resolve related issues
Lead and develop the Quality teams for each facility, provide focus as required, and ensure accountability for job responsibilities
Ensure adherence to required quality standards for each wine, an orderly flow of work, and the integrity of the final product
Develop a system and process for tracking quality issues across facilities and implement corrective and preventive actions in a coordinated and consistent manner
Identify and mitigate quality risks proactively through focused audits, FMEA’s and continuous improvement projects
Work closely with Bottling, Winemaking, Polyphenolics, Concentrate, Cellar, Distribution, Customer Service and legal partners to resolve quality issues in a timely and coordinated manner
Develop and implement procedures at each facility to support the Quality Management System
Develop strategies to support new product development initiatives from a quality perspective that align with the business strategy
Ensure lab management practices including, but not limited to, chain of custody, lot control, method validation and verification, QC charting, microbiology evaluations, documentation, recordkeeping, and error analysis are current and rigorously applied to daily activities
Bachelor’s degree, including 10+ year’s progressive experience in Quality, Compliance or a related technical field in the food or beverage industry (including alcohol beverage)
5+ years of managerial experience that includes an ability to effectively lead, manage, train and motivate a diverse group of employees to achieve high production within deadlines
Master’s degree strongly preferred
Experience with Quality Systems, HACCP, SOPs, GMPs, etc
Experience in food safety and environmental monitoring, as well as with sensory
Multi-site quality leadership experience highly preferred
Ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external customers
Ability to interpret complex technical data and apply to business decisions
Strategic and self-motivated with the ability to work and to achieve goals with a minimum of direction
Must be proactive in identifying issues and recommending solutions
Ability to build relationships with clients and internal teams

Corporate Quality Director Resume Examples & Samples

Develop and implement Total Quality program throughout the company which includes Sales, Operations, Supply Chain, Product Groups and Administrative areas
Develop and recommend corporate quality performance measures and standards
Review district quality performance measures on an on-going basis
Develop Corporate Quality vision
Coordinate audits and corrective action responses to maintain ISO/QS/AS/TS certification requirements
Identify and install Quality tools, education and metrics
Facilitate the transition to align the quality process focus toward the process improvement requirements of ISO/QS/AS/TS
Assist Supply Chain Group in providing suppliers / SPG’s with vendor performance measures to facilitate recognition/corrective action
Create and implement Total Quality action systems that reflect customer-level performance
Coordinate Executive Quality Council meeting to review corporate quality system on a quarterly basis. Recommend long term plans and initiatives
Develop and ensure implementation of all quality training
Coordinate quality recognition awards (i.e. President’s Quality Award, Virzi Quality Award)
Develop, implement, and monitor safety training and performance in all districts
Work proactively to ensure safety awareness is created and actions are taken to eliminate hazards and risks
Be a key member of Lean Manufacturing operations teams and Executive Steering Committee
Communication skills-capable of communicating effectively in both written and oral formats
Effective use of quality tools
Minimum 3-5 years quality management experience

Network Quality Director Resume Examples & Samples

Seven years relevant work experience; knowledge of inpatient and physician practice coding and billing processes required
Proven verbal and written communication skills
Critical thinking and creative problem solving skills required
Superior analytical abilities: ability to understand member’s business issues
Proven organizational skills and ability to balance multiple projects
Strong statistical and data analysis background
Experience in Microsoft Office products required, including Excel and Access databases
Experience in root-cause analysis procedures, lean process principles, quality techniques and action planning
EMR /EHR experience/proficiency