Director, QA Resume Samples

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N Dicki

Naomi

Dicki

402 Glover Drives

Dallas

+1 (555) 848 9055

402 Glover Drives

Dallas

Phone

p +1 (555) 848 9055

Experience Experience

San Francisco, CA

Director, QA

San Francisco, CA

McCullough and Sons

San Francisco, CA

Director, QA

Manage the QA team and inspire them to provide best in class service with continuous improvement
Define test methodologies and automation framework to provide high test coverage
Define and own the QA methodology with metrics-driven continuous improvement; analyze metrics and implement continuous process improvement
Demonstrate good leadership by providing an objective, high energy, consistent work ethic that promotes respect for the individual
Manage the team on multi-threaded project deliveries ensuring resource planning, schedules, and risk management
Analyzes test data and provide feedback for making process improvements
Report current status and continuous improvement metrics

Phoenix, AZ

Director, QA Technical Testing

Phoenix, AZ

Macejkovic-Strosin

Phoenix, AZ

Director, QA Technical Testing

Advancing the testing practice through innovative ideas using industry standard tools and technology
Provides technical leadership, mentoring and training to team members
Provides input into cross discipline councils for enhancing or creating new processes or tools to improve our Delivery model across the SDLC
Participates in Steering Committee meetings and ensure testing voice is heard
Researches emerging trends/best practices and determines implications of proposed methodologies on meeting business unit strategy
Leads planning and estimating of automation activities for large, multi-phase projects and programs
Leads the design of testing protocols and processes for optimum performance to improve efficiency and reduce costs

present

Phoenix, AZ

Senior Director, QA

Phoenix, AZ

Emmerich LLC

present

Phoenix, AZ

Senior Director, QA

present

Develop and implement a plan of continual improvement
A record of establishing programs of continual improvement via better processes and tools
Create an environment where cross functional teams enjoy working together by organizing team events, meetings, hack-a-thons and other creative activities
Be an advocate for agile development methodologies while delivering on all committed projects
Uses data to measure and improve overall team productivity and product quality
Provide timely and transparent written status reports that highlight both successes and challenges
An expert in Agile processes and the role of QA within that framework

Education Education

Bachelor’s Degree in Chemistry

University of California, Los Angeles

Bachelor’s Degree in Chemistry

Skills Skills

Comfortable leading and working with teams of developers and helping them establish a culture of quality
Comfortable communicating both good and bad news to all levels of an organization
Proven track record of achieving high quality Enterprise and SaaS releases and meeting commitments
Experience using data to drive the organization to make decisions about quality
Strong oral as well as written communication skills
Ability to speak the truth that no one wants to hear
Interest and passion in driving both functional & visual quality
Prior experience with the implementation of continuous process improvement methodologies (such as Six Sigma, Lean/Kaizen, Quality Function Deployment, etc.) is
Ability to travel 20% on average, including trips abroad
An expert in Agile processes and the role of QA within that framework

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Director QA Technology Deployment & Validation Resume Examples & Samples

Defining and managing the process for Investment Advisory Program user acceptance testing, including defect management
Collaborate with all stakeholders to develop detailed requirements, architecture, coding, and testing timelines to support aggressive delivery dates
Manage business testing activities for all releases of the Investment Advisory Program across multiple environment, test cycles, and applications
Coordinate testing between the business team, lines of business, vendors, including the solicitation and organization of resources based upon the specific needs of each release
Lead release events, make critical decisions around production readiness, defect deferral and prioritization of resources
Develop strategy for coordinating functional and regression test teams to ensure proper coverage, including the hand off of mature functionality to off shore resources
Manage the lifecycle of functional validation through multiple environments; including the organization of new test infrastructure to support the pace of Investment Advisory Program deliverables
Minimum 8-10 experience in financial services environment, developing technical roadmaps, writing requirements and working on deployment of projects, overseeing QA and testing of software
Substantial experience in a senior platform or product development position, with increasing level of responsibility
Knowledge of Managed Account platforms and products required
Strong leadership experience with demonstrable success owning and leading roll out of a major investment advisory platform or initiative
FINRA licenses 7 & 66, or able to obtain within 120 days
Bachelor’s degree required, advanced technical degree preferred

Director, QA Resume Examples & Samples

Build an A-team of QA engineers to deliver a high quality product
Define test methodologies and automation framework to provide high test coverage
Actively participate in development lead activities such as unit testing, code coverage tools etc
Participate in architectural and product planning activities
Coordinate all test activities including functional, system, and beta testing
Provide day to day technical guidance and hands on help to the QA team members
Provide reporting of quality metrics throughout the test phases
Analyzes test data and provide feedback for making process improvements
Deliver consistently in a fast-paced environment, giving attention to detail even under high-pressure situations

Director, QA Resume Examples & Samples

The OCW-based Director will be responsible managing the CIT QA team to support all Corporate Business Systems working in partnership with the application Support and Development teams to ensure a "center of excellence" for quality assurance
CIT QA will be aligned with Corporate Business System global initiatives, enhancements, and day-to-day operational Production defects. Tasks may include but are not inclusive of, Sizing, Test Plans, Test Case Creation, Test Data Creation, Manual Testing, Issue Management Resolution and Documentation
Lead and mentor QA team to drive testing methodologies and focus
Effectively plan and manage project delivery of QA resources, test strategies, test design and execution adhering to Visa's internal Testing Management Methodologies and industry best practices
Promote a standardization of QA processes and a discipline of QA testing throughout the team using Visa's TMM, assist to develop, execute, and standardize test plans
Ability to comprehend complex Business requirements and Technical solutions to provide mapping into Test Plans, Test Cases, and Test Scripts
Manage the team on multi-threaded project deliveries ensuring resource planning, schedules, and risk management
Oversee and provide guidance to QA resources managing defects from identification to completion
Publish standardized QA reporting and metrics for management and stakeholders
Partnering with staff deployed globally, including direct staff, vendors, and offshore partners
Manage QA project resources, forecasts and budgets
Identify, manage, and lead vendor based resources to support QA Initiatives when required
Understand application and platform dependencies and help define QA environment and infrastructure needs
12+ years of professional functional experience working with packaged ERP Applications and SAAS solutions
9+ years of professional work experience in Application Testing and QA best practices
8+ years of Oracle eBusiness Suite (Financials) experience
Experience with HR Application Solutions and Technologies
Experience with Financial Planning and Analysis Solutions and Technologies
Experience with GRC, Sourcing, and Corporate applications and technologies
Experience with Case Management Systems such as ServiceNow or Remedy
Experience managing and mentoring resources
Strong background and understanding of financial principles, concepts, practices, and standards
Experience with QA testing tools such as HP ALM and Rational ClearQuest
Experience taking complex business requirements and driving test designs to validate against the system design
Working knowledge of SDLC and experience in Test Execution including manual end-to-end regression testing and evaluation of test results
Strong verbal and written communication skills to communicate defects to management
The ability to self-govern, to be flexible, to prioritize and manage their own time (including resources) to meet tight program deadlines
Strong internal customer relationships are essential and this position will work with Business Partners, internal staff, external vendors and system integrators on a daily basis to ensure quality assurance is performed in alignment with global initiatives and requirements across the enterprise
Bachelor's degree in Computer Science or job related discipline is preferred. Advanced degree is a nice to have.

Director QA Testing Agile Group Resume Examples & Samples

Reviewing requirements for clarity and testability, through early engagement in the project
Defining the e2e overall test strategy, which includes test focus areas, test phases and roles, risk assessments, environmental requirements
Establishing quality metrics and measurements
Establishing, managing, and owning e2e test plan milestones and entrance/exit criteria
Governing, managing and enforcing the use of standards throughout the process
Championing the introduction of Continuous Process Improvement initiatives
Coaching and develop QA team capabilities, including testing automation and Agile engineering practices
Drive the adoption of Agile best practicies, and align with improved waterfall strategies as required for an efficient 2-speed delivery
Work closely with Infrastructure team, Release and Test Environment Management and development teams to create the capability to provision environnments to align with Agile requirements
Works with Delivery Managers and Development teams to ensure QA activities and schedules align with the overall project/program goals and milestones, and that cross platoform/end-to-end QA functions are performed
Partner with the QA Tools and Methodology to research, investigate and recommend process improvements and tools
Overall accountability for the QA activiites, cost, schedule, issues and risks for projects within the portfolio, including QA performed by contractors and vendors
Infuse testability early in the SDLC process and build testability into solutions
Integrate QA into solution design, requirements/scope management, code quality and releases/deployment
Ensuring consistent methodology is applied throughout the project lifecycle, across projects and teams; ensure test approach, artefacts, terminology ar aligned and well understood
Looks for ways to improve efficiency and effectiveness in QA activities, including using new tools and techniques, and encouraging use of automation and re-use of artefacts, processes and templates
Ensures integrated metrics are available and reliably report project progress
Facilitates resource planning at all levels to ensure resources are shared among projects efficiently; looks for continuous improvement in testing costs, timelines and quality
Effectively communicates and collaborates with team members, other IT&S departments, business lines and stakeholders
Sets direction and strategy for overall QA role and evolution
Owns quality results across projects and programs
Resolves issues and concerns with QA activities
Hands-on experience in developing overall test strategies, covering all areas and phases of testing
Excellent leadership and communication skills to direct and influence large groups at varying levels
Excellent interpersonal and negotiation skills
Banking industry and product knowledge is an asset

Director QA Resume Examples & Samples

The tasks this individual is responsible for are critical to the organization's future, have wide implications, and multiple outcomes
This individual will apply multiple decades of expertise or unique technical/industry knowledge in solving problems that are unique and extremely complex given time, budget and resource constraints
Demonstrate leadership and vision in determining and driving strategy decisions, process changes, business initiatives, etc
Education and Experience
2 years experience in a director equivalent role focused on systemic testing
A minimum of 15 years of experience as a people manager is required

Director QA-technology Group Resume Examples & Samples

Owner of Quality Assurance across all software delivery projects, working with Agile development team across multiple locations
Strategic Direction on QA function – working with multiple team across US and Europe, ensuring strategic alignment and process and toolsets
Enhance and build upon our established Automation Test Framework & drive continuous integration / delivery strategy to support this
Drive innovation and improvement across the QA team and our partner organisations. Develop a vendor model that supports this
Develop best-practice Automation & Manual Exploratory testing processes and procedures, and embed in Agile/Scrum processes
Plan and implement appropriate testing within a scrum delivery model and to determine both functional and non-functional testing within sprint and within release cycles
Work across the engineering teams to ensure alignment on QA automation processes and goals in-sprint
Develop a strategic development path for CI / CD
Operate within a fully virtualised environment (Amazon Web Services / AWS)
Implement appropriate balance of white box, grey box, and black box testing per product type and system requirements
5+ years as manager of a software quality assurance organization
5-10 years in Quality Assurance, with experience writing test strategies, test cases, and in test automation
Thorough understanding and knowledge of quality assurance processes, standards, methodologies, and tools
Build and release processes and protocols, with working knowledge of source control systems
New automated test procedures
Ability to analyze large amounts of data and determine system areas of deficiency for further testing
Strong interpersonal and proactive leadership skills

Director QA Resume Examples & Samples

Responsible for the vision, strategy and execution plan for the overall quality goals for the products at PubMatic
Responsible for setting, reviewing, and execution of the operational plan that compares well with industry best practices for comparable environments
Develop and implement programs to improve quality and performance of product
Introduce, develop, maintain, and periodically update the QA procedures manual and objectives and philosophies
Develop, maintain, and periodically update written policies and procedures that govern the day-to-day tasks of the QA function
Work closely with product managers on the implementation of new projects and infrastructures including operational readiness, change preparation, change execution, and post-change QA validation
Mentor and evangelize Agile, Lean, and Continuous Development testing best practices
Attracts, develops, retains and motivate top software testing talent and automation engineers. Maintains career path for QA, separating management and technical paths
2015: 1st to market with competitive benchmarking analytics for publishers

Director, QA-quality Operations Resume Examples & Samples

50%
Managing all quality operations to include testing of components, process intermediates, and final products for the Melville site ensuring release lead times are met with timely product disposition
Ensure that the QA teams are staffed with trained and qualified staff for the specific operational areas
Lead the communication of quality problem notification/ resolution between Manufacturing, QA, Engineering, Facilities, Validation, and R&D regarding out-of-specifications. Actively pursue timely response and final preventive resolution to quality issues. Share "best practices" globally across Manufacturing, QA, Regulatory, Legal and R&D as it relates to Quality Assurance
Participate in lead team meetings and staff meetings when appropriate
Manage and maintain Estee Lauders quality audit, inspection and product release programs for incoming, in-process and finished good materials
Lead and facilitate the non-conformance management process, along with consumer/customer complaint resolution and reduction activity
Review Quality Metrics and drive continuous quality improvements (systems, processes, capability). Define and implement action plans to positively influence scorecard results
Manage and maintain the component certification process for incoming components. Continuously build and sustain relationships with vendors ensuring appropriate corrective/preventive actions are effectively implemented
Determine & implement product dispositions regarding holds due to higher level quality & regulatory issues. Support determination & implementation of product dispositions regarding holds, warehouse, transport, & logistics issues. Serve as information manager in event of product recall
Work collaboratively with QA Labs, Manufacturing, Validation, Compliance, Mechanical Engineering, and Package Engineering to drive continuous improvement
Provide QA support, review and approval for relevant documents including relevant, test procedures, specifications, technical reports, trend reports, Annual Product Quality Reviews
Drive and sustain improvements in capabilities and processes as defined in relevant SOPs in accordance with all FDA/ global government agencies. This process includes testing, data analysis, reporting and recordkeeping according to corporate policies
20%
Accountable for providing strategic direction, leading and coordinating activities involved in implementation of best-in-class Quality Assurance operations
Responsibility for performance and development of all Quality Assurance operations staff
Work with Quality leadership team for proactive succession planning and a high performance culture through people
Mentor staff by providing focusing on ongoing personal and professional growth
Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year Provide the means for incorporating the necessary tools, equipment, and methods into the new and existing processes aimed at continuous improvement
Assist in the development and execution of quality training modules for the organization
Coaching, as the site expert, on the regulatory and compliance requirements in regards to GMP’s

Director, QA Quality Control Laboratories Resume Examples & Samples

Managing all microbiology, analytical and physical testing of raw materials, process intermediates, and final products for the Melville site ensuring release lead times are met with timely product disposition
Ensure that the QA labs are staffed with trained and qualified staff and appropriately trained resources are deployed
Lead the communication of quality problem notification/ resolution between Manufacturing, QA and R&D regarding out-of-specifications. Actively pursue timely response and final preventive resolution to quality issues. Share "best practices" globally across Manufacturing, QA, Regulatory, Legal and R&D as it relates to testing within the site QA laboratories
Participate in lead team meetings and staff meetings when appropriate. Work closely with R&D, Stability, Formulation, Compliance, Regulatory and QA as appropriate
Ensure regulatory readiness
Oversee Implementation of test methods and procedures
Work collaboratively with QA, Manufacturing, Validation, Compliance and R&D to drive continuous improvement
Provide QC support, review and approval for relevant documents including relevant, test procedures, specifications, technical reports, trend reports, Annual Product Quality Reviews
Ensure Safety and Quality standards are reliably maintained and comply with Estee Lauder global guidelines and regulatory requirements
Drive and sustain improvements in the analytical, products and microbiology labs in regards to capability and process as defined in relevant SOPs in accordance with all FDA/ global government agencies. This process includes testing, data analysis, reporting and recordkeeping according to corporate GMPs
Accountable for providing strategic direction, leading and coordinating activities involved in implementation of best-in-class Microbiology and Analytical lab operation
Responsibility for performance and development of all Quality Control staff
Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year
Ensure staff receives appropriate knowledge and skill development and growth opportunities
Coaching, as the site expert, on the regulatory and compliance requirements in regards to GMP’s within the labs (GLP’s)
Keep abreast of industry best practices as it related to the efficiency of stability testing and adherence to FDA/ ICH guidance documents
5% Travel

Senior Director, QA Resume Examples & Samples

Develop and implement a plan of continual improvement
Drive the organization’s efforts for improving our automated tests and reduce time to market for our SaaS offering
Be an advocate for agile development methodologies while delivering on all committed projects
Uses data to measure and improve overall team productivity and product quality
Work with Product Management, Design, Development and operations to negotiate and offer alternatives on risky/complex/expensive requirements and negotiate priorities and timelines
Collaborate with other members of the Learn product development staff to develop a true sense of shared responsibility & energy for the entire product, from conception thru deployment
Recruit, mentor, organize, motivate and coach a team of software quality engineering professionals. Assign projects and arrange training to advance the career of each individual within the team. Define and monitor goals.Identify and coach future leaders to take on additional personnel and technical responsibility.Help partners improve the quality of their add-ons
Enable collaboration between team members and others across the product development organization in an effort to best leverage the skills and knowledge of all engineers
Create an environment where cross functional teams enjoy working together by organizing team events, meetings, hack-a-thons and other creative activities
Expect to be traveling approximately monthly, mostly to other Blackboard offices
Proven track record of achieving high quality Enterprise and SaaS releases and meeting commitments
An expert in Agile processes and the role of QA within that framework
Comfortable communicating both good and bad news to all levels of an organization
Experience using data to drive the organization to make decisions about quality
A record of establishing programs of continual improvement via better processes and tools
Ability to speak the truth that no one wants to hear
Interest and passion in driving both functional & visual quality
Experience influencing the practices of other product teams with the company, including design, engineering, and operations
Comfortable leading and working with teams of developers and helping them establish a culture of quality
Managed large global teams

Director, QA Resume Examples & Samples

Develop and lead the testing process across web, mobile, connected TV and supporting infrastructure services
Build and lead a team of QA engineers in a fast-paced, innovation-led, agile environment
Partner with product and engineering leaders to improve the quality of software of the software we build
Work with our partner vendors to ensure the delivery of high quality software
Identify cost effective ways to scale testing by using outside partners as needed
Own the end-to-end testing environments ongoing build out of our device test lab

Director, QA Resume Examples & Samples

Management and hands-on development and maintenance of test plans and test cases covering functional product, integration and automated and manual regression testing
Plan test execution cycles to meet product and integration release schedules
Monitor and de-risk activities from initiation through delivery
Certify and approve product releases for delivery
Define and own the QA methodology with metrics-driven continuous improvement; analyze metrics and implement continuous process improvement
Report current status and continuous improvement metrics
Manage the QA team and inspire them to provide best in class service with continuous improvement
Collaborate with Product Management, Development and Support teams to foster a team-based approach to high quality launches and drive appropriate changes in those organizations to ensure high quality deliverables
Review, assess scope, risk and coordinate application change management processes in compliance with policy and best practices
Demonstrate good leadership by providing an objective, high energy, consistent work ethic that promotes respect for the individual
Maintain QA staff results by coaching and counselling employees; planning, monitoring, and appraising results

Associate Director, QA Compliance Resume Examples & Samples

Provides Global Quality Compliance direction to Business Unit(s), local sites, and others as needed to establish and implement practices and procedures that comply with applicable regulations, current industry and regulatory guidelines, and Alcon/Novartis global standards
Provides compliance guidance to critical investigations (e.g., non-conformance, OOS, deviation, complaints, etc.) to ensure that issues or events are escalated as required, reporting requirements to regulatory authorities are met, and that investigation, analysis, corrective/preventive actions, and documentation are comprehensive and timely
Performs detailed audits of practices at company manufacturing plants and sites to ensure that policies and procedures comply with guidelines set forth by all applicable regulations both domestic, international, and applicable ISO standards
Consults with manufacturing management to establish practices and procedures that comply with all applicable regulations
Work with manufacturing sites to coordinate inspection management for Novartis and Health Authority audits/inspections
Coordinate and review responses to Health Authority observations and queries/reporting regarding market actions
Coordinate Compliance Alert analysis with manufacturing sites and prepare Divisional summaries for approval and submission to Novartis
Prepare and present regulatory and Lessons Learned Information via Compliance Forums
Coordinate and manage to closure Field Action Assessments and market actions
Review escalations for immediate action and follow up
Perform gap assessments for Novartis Quality Directive / Module changes
Review and assess new / revised industry and regulatory standards for Division impact

Senior Director QA Resume Examples & Samples

Displays integrity, ethics and trust and holds self and others accountable
Results-oriented and displays high energy and enthusiasm
Motivates and inspires others by managing vision & purpose. Action orientated, drives for results
Identifies talent and builds teams to increase performance across the company
Proven conflict resolution skills
Ability to manage unexpected situations and be comfortable with ambiguity
Strategic agility and customer focus: converts strategies to tactical actions and objectives for the organization to deliver value to the customer
Ability to make decisions based upon both short and long term global strategies
Intellectual horsepower/good analytical skills/data driven
Priority setting based on QA/RA, business and customer focus context

Associate Director, QA Compliance Resume Examples & Samples

Manages the development and revision of the Controlled Documents System and training program internally at Akebia to ensure compliance with applicable FDA and other regulatory agency requirements and guidance documents
Provides quality oversight and support to drug product and drug substance contract manufacturing operations in the following key areas; batch record, analytical laboratory operations, equipment and facility, and materials management
Developing, implementing and improving a Quality System for Lot Release and Disposition of Drug Substance and Drug Product intended for use in clinical trials, as well as commercial use
Responsible for clinical batch disposition. Review batch data, including batch records, deviations, QC release testing and other quality systems as applicable to determine acceptability of product disposition
Contributes to the development and implementation of the corporate strategy for GXP compliance
Assist in Investigations, Corrective and Preventive Actions, Change Control and providing general quality assurance support
Support internal and external GXP audit plans for Akebia development programs
Lead regulatory support as needed for GXP, QA–related issues and interactions, both internally and with external vendors
Read and interpret new and current compliance manuals, guidance documents, and regulatory enforcement trends/actions, and disseminates information, as needed
Develop and provide training programs, develop training as needed
Maintain all associated tracking logs,
QA lead in the development and implementation of pre-approval inspection readiness plans and help manage Akebia activities during regulatory inspections
Provides Quality input in multifunctional clinical working groups when requested
Represents Compliance and QA department at CMO meetings
Bachelor's degree in chemistry, engineering or other scientific discipline with 10+ years of GXP related experience
4+ years of experience specializing in GCP focused programs preferred (QA experience in the Pharmaceutical industry required)
2-4 years of experience in a supervisory/management capacity preferred
Excellent knowledge of GCP regulations
Knowledge of FDA, EU, and global requirements and guidelines related to cGMP operations
Experience with traditional solid oral dosage manufacturing
Experience in managing documentation systems and Electronic Documentation Management Systems
Experience in managing training programs and Electronic Learning Management Systems
A strong understanding of GxPs and an ability to apply them to clinical research and/or related processes is required
Working knowledge of analytical instrument qualification and method validation in support of GMP laboratory operations
Experience in hosting regulatory inspections in support of clinical trials and/or commercial operations
Excellent technical report writing skills
Strong Communication, interpersonal and problem solving skills and detail oriented

Assoc Director, QA Resume Examples & Samples

Supports the distribution warehouse with focus on compliance with applicable China GMP Quality Management System, Quality System Regulations (QSR), ISO 13485 requirements and GDP Good Distribution Practice
Ensures adequate control of nonconforming material
Manage investigations, disposition and CAPA processes
Develop, review and approve Quality System documents (e.g., Standard Operating Procedures, Forms, Specifications, Validations, etc.) to ensure compliance with applicable regulations (e.g., GMP, GDP, QSR, ISO, etc.)
Monitor and analyze key metrics and drive improvements to distribution processes
Facilitate the training program required for Illumina customer facing personnel
Ensure that records are complete, accurate and timely
Support development and executions of process verification and validation plans
Review and approve planned and unplanned changes/deviations
Collaborate with the Global Quality team to oversee, support, facilitate and/or drive the following areas:-

Director, QA Compliance Resume Examples & Samples

Provide general compliance oversight for Hayward and Boston operations ensuring compliance with regulatory requirements and Intarcia standard operating procedures
Support the design, implementation and maintenance of the quality systems procedures and policies to ensure compliance with the current regulations and all applicable regulatory requirements
Responsible for managing all GxP compliance activities in collaboration with Quality and Regulatory to ensure compliance with US and global regulations including our regulatory submissions
Support activities associated with Vendor Management; developing quality agreements, risk assessment, and conducting audits
Manage all internal and external customer queries with respect to regulatory compliance and quality matters
Manage and conduct mock inspections, internal audits, data integrity audits, initiate CAPA plans from audit observations, and execute remediation actions to ensure compliance to regulations and closure of non-compliance observations
Compile and maintain compliance metrics for audits and CAPAs
Promptly escalate all compliance issues to Quality and Sr. management, track compliance metrics and prepare management reports regarding compliance activities and governance
Evaluate and interpret US and Global regulations, guidance’s, standards to ensure that the site and product complies with all applicable regulations and submissions
Ensure all GxP activities are conducted in compliance with the relevant food and drug regulations (US and Global)
Host and manage all GxP regulatory inspections (FDA, EU, Global, and Notified Body including Partner QP audits)
Primary contact for regulatory correspondence with the local district office on quality matters; collaborate with QA and respond to audit observations, initiate NDA Field Alert Reports, Recalls and product retrieval
Provide employee training on compliance related topics, policies, or procedures
Bachelor of Science degree in a scientific discipline is required. An advanced degree is preferred
A minimum of 10+ years of experience in the pharmaceutical, or combination products industry hosting and managing compliance and/or quality responsibilities including regulatory inspections
Strong working knowledge of FDA regulations (21CFR4, 210/211, 820), ICH Q10, IS0 13485, and global regulations (EU Directives, and ROW)
Proactive in identifying opportunities for continuous improvement along with strong problem solving skills
Leads by example and highly collaborative with a proven ability to work in the cross-functional team environment
Strong verbal, written communication skills are required
Strong computer skills required including Microsoft Excel, Word, and PowerPoint
Able to travel (10-25%)

Associate Director QA Site Microbiologist Resume Examples & Samples

Responsible for improving upon and maintaining the general facility bioburden program and remediation efforts where necessary
Lead investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination and remediation plans. Work in concert with the director of QC Microbiology to achieve these goals
Maintain industry standards with respect to microbial control and mitigation – incorporate any new industry standards/use of new monitoring equipment into the IOPS system
Provide input on technology transfer plans related to microbiological method transfers (method validation)
Develop and provide input on the development and modification of microbial action limits
Review and provide input on microbiology SOPs, microbiology assay validation and related documentation
Review and provide input on environmental monitoring SOPs and validation
Review and provide strategic support to understanding and managing bioburden trend levels. Reports excursions and their interpretation to senior management
Responsible for constantly assessing the effectiveness of IOPS sanitization agents
Domestic and foreign travel required
Strong writing skills are essential
Excellent interpersonal and leadership skills and abilities
Ability to interpret and communicate information
BS in Microbiology, medical technology, biology or related field and a minimum of 10 years’ experience in the pharmaceutical or biotechnology industry is required. Higher degree preferred. Experience in qualifying clean rooms, clean utilities and manufacturing processes is necessary. Experience should also include quality control microbiology, quality assurance and regulatory inspections for Biological pharmaceuticals

Director / Associate Director, QA Operations Resume Examples & Samples

Defines and implements quality standards, systems, and metrics for clinical and commercial operations
Compiles, organizes, and presents metrics for areas of responsibility to senior management
Provides leadership and coaching to personnel
Organizes QA resources to meet goals and timings, coordinates prioritization of activities with area management
Performs compliance monitoring of area operations, including trending of NOEs/EOEs, and DNFs and evaluating effectiveness of corrective actions
Reviews customer/partner/supplier requirements and responsibilities, implements required processes/agreements, as needed, to meet expectations regarding quality
Participates in preparation for and execution of regulatory and customer audits. Ensures audit observations are addressed appropriately and completed on schedule
Ensures safety and operational standards are maintained
Approves various documents related to area function
BS or higher degree in life sciences discipline or related field (chemistry, biology, or pharmacy preferred) with experience in a pharmaceutical/biologics manufacturing environment preferred. Experience with QA systems such as change control, investigations, deviations, CAPA, document management systems, etc.required
Minimum 10 years experience in pharmaceutical industry; biologics experience preferred
Minimum 3 years experience in supervisory or managerial position

Associate Director, QA Compliance Lead Resume Examples & Samples

Lead and be responsible for Quality Assurance for all cGMP activities overseen by TBU at Contract manufacturing and contract testing laboratories globally. Responsible for all aspects of external cGMP Quality Assurance, including developing operating philosophies, establishment and maintenance of a Quality Culture, ensuring adequate numbers of appropriately skilled QA and validation personnel to support workload, and establishing quality systems in alignment with Teva Global Standards and international cGMP regulations
Lead Quality assurance for technology transfer, Process validation and transport validation, serve as product quality leader throughout the product lifecycle
Partner with Biologics QA representatives globally to ensure alignment and incorporate best practices
Define vision for process validation. Ensure Review and approval support for process validation protocols, master plans, and reports
Provide contract manufacturing and contract test lab oversight, help develop and ensure alignment to quality agreements, review and approve CMO/CRO records, change controls, deviations, and reports
Serve as Teva’s Quality Assurance leader in work with Contract Research Organizations (CRO) and Contract Manufacturing Organizations on product implementation and technology transfer, Quality Agreements, Audits, and support for inspections
Lead the creation of a Quality Culture
Ensure progress at TBU and CMO/CRO to prepare for Regulatory filing and inspections to ensure success
Serve where required as Teva’s Primary Quality Assurance representative in regulatory agency inspections and partner/Teva Audits, and coordinate inspection response strategy

Executive Director QA Labs Resume Examples & Samples

Manages staff and quality assurance initiatives in PPD global laboratory locations
Role includes focus on Global Central laboratories (GCL), Bio-analytical labs (including vaccines) & cGMP lab
Assigns work and reviews workload for all direct reports
Establishes goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level
Recommends and approves courses of action on all management / human resources’ matters
LI-DR1
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 to 15+ years) or equivalent and relevant combination of education, training, & experience. 5 to 10+ years of management responsibility
Excellent knowledge of Quality Assurance methods
Thorough knowledge of ICH-GCP, GCLP and/or GMP/GLP
Demonstrated ability to collaborate and align QA with operations
Experience in writing and reviewing Standard Operating Procedures
Strong problem solving, risk assessment and impact analysis abilities
Solid experience in CAPA review
Demonstrated experience in process improvement
Strong negotiation and conflict management skills
Familiar with QA information management systems and Laboratory Information Management systems
Ability to think independently and influence when appropriate

Director, QA Resume Examples & Samples

Passionate about creating an enterprise-grade testing approach
Proactively maintain high quality standards through systematic metrics-driven test planning and test execution and driving continuous improvements appropriate KPIs
Manage and mentor a global team of engineers and software testers
Collaborate with team and ensure that software meets or exceeds specified standards and end-user requirements
Proactively provide functional, regression and integration testing of our SaaS products as well as certification across browsers and devices
Daily review and monitoring of de-risk activities from initiation through delivery

Director, QA Resume Examples & Samples

10+ years Software Quality Assurance experience (not just Quality Control)
7+ years of leadership experience at Manager/Director level running quality organizations with distributed teams
Possess strong working knowledge of quality assurance methodologies and familiarity with modern test technologies and tools such as Selenium, etc
Have a passion for light weight, effective processes and methodologies that will improve the productivity of the organization
Understand different deployment methodologies such as continuous integration and continuous deployment
Must have experience in understanding and partnering test automation initiatives
Must be well-versed in manual web-based testing
Ability to contribute at all levels of testing including unit, functional, automation, performance and scalability testing
Familiar with all of the test-related aspects of the software development life cycle
Excellent oral and written communication skills as necessary to communicate plans and status to all levels within the company and to build and maintain a highly effective QA organization
Familiar with .NET back end as well as SQL Server
Familiar with black box testing, white box testing and mobile app testing
Knowledge of SCM (TFS, git, etc.)
Experience in software engineering fundamentals (has programmed)
BS in a technical degree in engineering/computer science or equivalent experience

Director QA & RA Medical Resume Examples & Samples

Establishes quality and regulatory strategic goals by gathering quality, business, financial, service, and operations information; identifying and evaluating trends and options; choosing a course of action; defining objectives; evaluating outcomes
Provide guidance on development of procedures that maximize quality and regulatory standards; establishing and directing manufacturing sites on manufacturing quality and regulatory testing (incoming, in process and final release), including laboratory facilities for quality and regulatory testing of raw materials, finished goods, and goods in process
Develops strategies and implement programs to assure regulatory compliance and standards of quality and regulatory. Provides leadership in responding to FDA and other regulatory agencies in trends and GMP requirements. Manages GMP compliance audit programs. Executes control over all or some of the following programs/systems: change control, documentation control, product complaint investigation and analysis. Maintains quality and regulatory service by enforcing quality and regulatory and customer service standards; analyzing and resolving quality and regulatory and customer service problems (customer complaints, customer audits, customer surveys and/or quality and regulatory agreements, etc.); identifying product quality and regulatory trends; recommending corrective actions, (product quality and regulatory and/or quality and regulatory system improvements; conducting audits and follow up
Provide leadership and guidance on design for quality and regulatory to new product development staff. Serve as Stage Gate QA Sponsor – review /approval of project prior to release to next stage of design/development/launch. Activities typically include reviewing designs/plans of proposed new products
Reviews technical problems and procedures of departments by recommending solutions to problems or changes in procedures
Maintains professional and technical knowledge by attending educational workshops’ reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; and participating in professional societies
Accomplishes staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, counselling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures
Initiate and support workshops / Kaizen events to continues improve standard work and performance
Oversight over company policy and system for notifiable events (vigilance system, MDR ) globally
Master degree in a Life Sciences discipline
Knowledge of ISO9001, ISO13485, 21 CFR 820 and ASIEN regulatory requirements
Minimum 7 years’ experience in Quality Management systems
Significant experience in data analytics and problem solving

Associate Director, QA Clinical Compliance Resume Examples & Samples

Develop/revise/implement/adhere to departmental policies and procedures affecting Quality Assurance
Assist with maintaining file organization within the Quality Dept
Remain in compliance with Training program
Perform other duties as defined
Bachelor and/or Masters in a healthcare and scientific-related discipline, or equivalent work experience is highly desirable
10+ years of GCP/GLP/PV quality assurance experience in a pharmaceuticals or biotechnology industry
Good understanding of Clinical Development Process
Experience writing and reviewing SOPs which support clinical trials
Good understanding of FDA GCP and ICH regulatory requirements and implementation
Good knowledge of Computer System Validation in association with GCP/GLP/PV audits
Effective communication (verbal and written)
Strong interpersonal skills, team player, and flexible without compromising quality
Ability to manage multiple projects in a dynamic environment and ability to meet fast-track timelines
Ability to travel 50% (domestic and international), sometimes on short notice
An ability to be productive and successful in an intense work environment

Associate Director QA Compliance Resume Examples & Samples

Site internal audit program
Coordination and management of site regulatory and GQA inspections
Timely development and closure of internal and external audit responses and CAPAs
Serves as the primary site contact for the Genzyme Corporate Quality Operations (CQO) department, and coordinates the site review, deployment, gap analysis, and implementation activities for GQS Standards, Global Operating Procedures (GOPs) and Practice documents
Monitors the site's progress throughout the Standard review and implementation process through the appropriate use of status reports and metrics
Ensures appropriate reporting and escalation of issues to the Tier 3 Quality Council
Participates in the development/writing of the site risk profile report to ensure all high risk gaps identified through global standard review are highlighted in the SRPR
Implementation of Genzyme Global Quality Standards

Associate Director, QA CMO Resume Examples & Samples

Release Drug Substance and Drug Product lots without disrupting supply
Critically evaluate product deviations, change controls, and product complaints and provide technical and quality input to support investigations
Prepare annual product reviews
Lead efforts to generate and/or revise Quality & Technical Agreements with CMOs for small molecules
Perform lot assessments as needed
Support Regulatory filings
Support product launch activities
Support regulatory agency, partner and QP inspections
Support process validation activities
Excellent leadership, technical, management, problem solving and project management skills
Strong technical background with experience in manufacturing and/or testing of small molecule drug substances or drug products
Organizational and management skills to handle multiple functional groups, with ability to effectively delegate work
12+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency of quality systems
7+ years experience in a management or supervisory position
This position will oversee a group of 4 full time employees (including 1-2 direct reports)
This position will lead and oversee multi-functional teams of 12+ people

Senior Director, QA Resume Examples & Samples

Oversee / direct the activities of Quality Assurance units with responsibility for Quality Systems
Responsible for ownership of the Sunovion Inspection Readiness Program including readiness activities, inspection management, and development/management of any resulting corrective and preventive action plans
Provide guidance on inspection readiness activities to DSP Companies and contract suppliers
Provide guidance and consultation to executive management, business process owners, and outside services vendors for the implementation of Quality Systems. Monitor for domestic and international changes to the rules, regulations, guidance documents, and industry trends, and update Quality Systems accordingly
Lead Quality System initiatives to ensure GMP, GCP and GLP compliance with applicable worldwide regulatory agency requirements. Ensure the development of policies, compliance standards, SOPs, test and inspection methods, and other quality documents to ensure full compliance with global regulatory requirements
Provide leadership and direct activities for validation efforts including ensuring that the facilities, equipment and processes used for the manufacturing and packaging of drug and device products have been properly commissioned, qualified, and validated
Lead and manage the commercial Change Management Quality System. Responsible to ensure that changes are appropriately assessed, justified and documented. Ensure liaison with Global Regulatory CMC Team for regional and global changes to Global products
Lead and manage ownership of the Investigations and CAPA Quality Systems ensuring appropriate investigation and timely closure. Evaluate investigations data for trends and ensure CAPA effectiveness
Responsible to lead and manage the Product Quality Complaint program ensuring appropriate investigation, timely closure and responses to complainants. Evaluate complaint data for trends and implement CAPA as required
Responsible for Field Alert assessment and reporting activities ensuring compliance with 21 CFR 314.81(1)
Partner with Supply Chain to drive Supplier Relationship Management efforts
Provide leadership and direct the activities for Annual Product Reviews including facilitation of the review of information and documentation of conclusions and recommendations of the APR review committee
Develop and direct projects that drive Continuous Improvement. Provide consultation and leadership to business process owners for the implementation of quality improvement projects
BA/BS required, preferably in a science-related discipline. A Masters or Doctorate-level of education is a plus
10+ years of relevant experience in FDA-regulated biotechnology, pharmaceutical, or medical device companies, with an emphasis on drugs/biologics
Expertise in GMP as well as a strong knowledge of GLP and GCP. Must be a hands-on technical professional with a comprehensive knowledge of current pharmaceutical-industry quality standards, international expectations for quality systems, and applicable FDA and international regulations and policies
Ideally 10 years of supervisory/management experience, with at least some of that experience involving managing cross-culturally and/or internationally
Must have experience managing domestic regulatory agency inspections, regulatory compliance, and quality systems implementation
Prior experience presenting to senior/executive management
Prior experience with the implementation of continuous process improvement methodologies (such as Six Sigma, Lean/Kaizen, Quality Function Deployment, etc.) is a plus
Ability to travel 20% on average, including trips abroad

Executive Director, QA / RA PMO Resume Examples & Samples

Establish Quality and Regulatory strategies to support high-impact business opportunities and to ensure that the necessary resources to support such opportunities, and risks, are identified in advance of project execution
Provide day to day Quality direction to ensure that teams deliver on their commitments, Quality Plans are executed, and ensure that Quality and Regulatory milestones that must be achieved are met without delay
Work with a broad range of management levels ranging from individual contributors to Executive Leadership Team. Lead and navigate complex projects through to completion while managing multiple stakeholders. Ensure that QA/RA transformation plans are aligned with the company's goals and accountabilities
Provide timely and accurate information to senior management and the core team regarding project plans and status. Collaborate with functional management across Hill-Rom to ensure organizational alignment
Establish, deploy and execute project management best practices in ensuring that Quality and Regulatory strategies are properly achieved
Facilitate and drive change in a fast paced and “ever changing” environment leveraging his/her strong interpersonal skills. Act as a key driver of change within the business, supporting management/cross functional decisions by communicating the enterprise-wide strategy to employees and helping them to learn, understand, adjust and grow with the business’s transformation
A minimum of 10 years of progressively increasing responsibility and leadership in establishing Quality and Regulatory strategy, managing influence among multiple departments, interacting with employees at all levels of the organization, and delivering concrete results which yield lasting impact on the Quality culture of the business
A B.S. in Engineering or closely-related field, with a Master’s Degree preferred
Demonstrated ability to drive cultural change at all levels of an organization to deliver results in projects without having direct supervisory responsibility over the people doing the work of the project. Strong change management and influence skills are required, and the ability to negotiate and communicate at different levels of an organization is essential
Strong knowledge of global Regulatory standards including 21CFR820, ISO 13485, the Medical Device Directive and other country requirements. Strong knowledge of best practices in all aspects of the Quality Management System is essential
Excellent problem-solving and negotiation skills along with a strong focus on problem solving is required. The successful candidate must possess strong influence skills to be able to drive progress beyond his or her departmental authority
Must possess excellent communication leadership and team building skills and have experience with multifunctional teams. They will have a strong customer orientation and strategic focus
Must be a leader who has the vision and courage to pursue big ideas, manage risk and encourage smart experimentation, and bring innovation to the organization
Must demonstrate a proven ability to distill complex strategy into simple actions, make decisions effectively, create focus and deliver results in a global environment
Must perceive change as an opportunity
Ability to work with ambiguity, little supervision and be a self-starter

Senior Director, QA Validation.maus Resume Examples & Samples

15+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency of validation and quality activities
10+ years experience in a management or supervisory position, with direct experience overseeing validation / quality assurance activities
Experience and expertise working with biologics; familiarity with solid dosage forms, drug-device combination products and/or gene therapy a plus
Experience in participating in regulatory inspections, presenting/defending departmental functions in audits or regulatory inspections (specific experience in defending validation preferred, but not required)
Ability to comprehend technical information related to facilities, utilities, equipment, processes, computer validation, scientific approaches, and regulatory expectations
Understanding and familiarity with FDA & EMA regulatory requirements, guidelines, and recommendations for departmental functions (understanding of regulatory guidelines for other countries a plus)
Good report writing skills for regulatory review

Associate Director, QA Systems & Compliance Resume Examples & Samples

Oversee the department activities regarding quality systems and compliance: change control, document control, GMP training, product complaint handling, internal and external audits, supplier quality management and metric reporting
Responsible for ensuring that the required initial and continuing training of direct reports is carried out and adapted according to need
Coordinate activities and assist with interactions during regulatory agency inspections and customer audits
Oversee the Internal Auditing Program and ensure that it drives continuous improvement of site quality systems
Participate in continuous improvement efforts and implementing policy as part of a leadership team
Responsible for the monitoring of site and 3rd party contractor compliance with the requirement of GMP and various drug Regulations
Perform audits of external suppliers as needed
A motivated self-starter; detail and results oriented; well organized, efficient leader with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
Highly effective coaching abilities as well as a successful track record of developing direct reports
Strong aptitude for facilitating group or project team endeavors, and building team unity
Ability to interact well with diverse groups, and maintain collaborative working relationships with internal and external partners
Must have experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues and to increase others knowledge of US end European GMP regulations and guidance

Associate Director QA Operations Resume Examples & Samples

Has final decision authority and accountability for Bulk Drug Substance disposition for commercial materials at Syracuse
Accomplish business results through leveraging a team of professionals and/or managers. Develops innovative solutions to problems without precedent; challenging the status quo to invent new processes to achieve strategic business objectives
Analyzes and forecasts scientific/technical trends. Accountable for ensuring deviation investigations are based on sound scientific rational and appropriate actions are taken to prevent recurrence
Develops, implements and directs operating procedures for the site quality assurance program which assures effective shop- floor quality presence; material release (raw and in-process materials as well as finished product); investigation and resolution of deviations, CAPA, and complaint investigations
Co-lead the site team which prepares for, hosts and responds to regulatory inspections, and regulatory reviews of the facility and products
Defines departmental roles and accountabilities and, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives
Ensures that all QA Operations personnel have adequate training, education and experience to perform their GMP related job function effectively
Manages staff that reviews and approves all executed batch production records and laboratory testing results before release of the product for distribution to assure that no deviations have occurred, or if deviations have occurred, that they have been fully investigated
Participate in BPDR investigations as required
Performs shop floor and lab walk through audits and challenge adherence with area procedures. Provide coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy
Performs complex work-flow analysis on processes impacting multiple areas across the organization to Ensure alignment with BMS directives and industry guidance on biologics manufacturing, validation and quality. Works in partnership with management to develop business plans that support the direction of the business. Develops complex solutions to problems through in-depth analysis, coordination and negotiation with key stakeholders and decision makers
Manage and execute operating procedures for the site quality assurance program which assures effective shop- floor quality presence; investigation and resolution of deviations, CAPA, and complaints investigations
Provide quality oversight of start-up activities including approval of master and executed production batch records, and associated process, documentation
Oversee and provide guidance to the Field Quality team, ensuring open internal/external communication and timely/collaborative issue resolution
Demonstrated expert knowledge and broad understanding of multiple disciplines is a must
Expert knowledge of FDA, EU and ICH regulations and guidance and cGMPs
Demonstrated expertise in root cause investigation and experience leading high-level compliance investigations
Strong background and demonstrated effectiveness in product release, quality assurance operations and compliance of commercial biologics in a FDA regulated environment
Demonstrated leadership, interpersonal, communication and motivation skills with evidence of building, growing and transforming an organization is required
Strong communication skills and experience in preparing for and interacting directly with regulatory and external inspection auditors
First-hand experience and knowledge of biologics bulk and finished product manufacturing and analytical testing is highly desirable
Demonstrated ability to understand topics which are often complex and technical in nature with an ability to apply sound judgment and appropriate quality risk management principles in the decision making process
Knowledge of SAP, LIMS, Maximo and Trackwise or equivalent quality systems is required
Knowledge of Delta V and Syncade is desirable
BSc in science, biochemistry, engineering or related discipline
At least 12 years’ experience in pharmaceuticals or biologics industry with at least 5 years in Quality Assurance and increasing management responsibility
Primarily an office based position requiring sitting for prolonged periods, walking, repetitive use of arms, hands, wrists
Primarily office space. Occasional exposure to both manufacturing and laboratory facilities where one must don appropriate gowning and personal protective equipment and be aware of the presence of workplace hazards including pressurized liquids, gases, high temperature water and steam, ultralow temperature cryogenic liquids and chambers, and hazardous chemical reagents
This position may require up to 15% of travel
Direct and indirect reports- approximately 20 total

Director QA Release Resume Examples & Samples

Leads the establishment of a performing, data driven QA release organization being capable to support the different operations on the site
Ensures during the project phase the establishment of state of the art electronic batch records for a fully paperless facility
Leads the design of lean QA review systems using electronic solutions by applying review by exception principles
Once the facility is operational, manages all activities related to QA batch record review and release according to CSL Behring Recombinant Facility AG licenses
Is responsible to manage and execute the transfer of QA operational activities from external manufacturing operations to Lengnau
Requires a university degree in chemistry, biochemistry, biology or pharmaceutical sciences or related field

Director QA & RA Medical Resume Examples & Samples

Ability to collaborate and communicate globally and cross-functionally
Ability to work effectively in a global, matrix organization
Customer advocate
Experience leading FDA inspections and Notified Body audits

Director, QA Operations Resume Examples & Samples

Build and develop a high performing quality assurance team
Directs and oversees the quality planning processes; participates in strategic and tactical planning processes
Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively
Communicates and reports regularly to executive management, users and staff on the status of the quality system
Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
Assure that there are no significant interruptions to the business due to quality or compliance issues
Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations
Lead employee development, communication and training programs in connection with the company's strategic goals, quality objectives, and operational systems
Bachelor's Degree in engineering, biology, chemistry, or related field
Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
Minimum 15 years of experience in quality engineering and /or quality systems
Medical Device industry experience, preferably IVD
Expert knowledge of US FDA and ISO requirements
Five years of Supervisory or Department Lead experience in managing both processes and resources
Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity
Develop strategic goals and objectives from knowledge base and understanding of a customer’s business
Manage changing conditions, processes and approaches; lead organizations through change effectively
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals

Associate Director QA Computer Systems Validation Resume Examples & Samples

Provide QA oversight of all GxP computerized system validation activities for enterprise applications and laboratory instruments across the company: conduct validation impact assessments, conduct/lead risk assessments, review and approve all validation related documents (e.g. validation plans, all specifications, protocols, reports, etc.)
Work closely and collaboratively with the Information Technology department and computer system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications
Lead and/or support development, implementation, improvement, education and enforcement of computer validation systems, policies, processes and practices
Assist in audits of select computer system vendors
Lead inspection preparation activities related to validated GxP computerized systems, train employees in inspection requirements, and participate in regulatory inspections, defending validation activities related to computerized systems
Maintain current knowledge of industry standards and regulatory requirements for computerized systems utilized by BioMarin
12+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency of quality systems, lot release and quality activities
7+ years experience in a management or supervisory position, with direct experience overseeing quality assurance activities
Ability to comprehend technical information related to computer software (operating systems, software applications), computer and network hardware, and the associated regulatory expectations relating to them
Experience and proficiency with industry standard enterprise system applications (LIMS, SQL, MES, eDMS, ERP, CMMS). Experience with TrackWise, Oracle’s ERP a plus
Practical understanding of CFR Title 21 (parts 11, 210, and 211), GAMP, Annex 11, data integrity guidance and e-record/e-signature standards and guidance
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation activities. Understanding of regulatory guidelines for other countries a plus

Director, QA Biologics Resume Examples & Samples

Partners with Pharmaceutical Development, Biologic, to develop and implement the Pharmaceutical Development strategy for new drug candidates
Partners with Pharmaceutical Development, Biologics, to identify and qualify manufacturing facilities for the Development, Manufacture, Testing and Packaging of Clinical product (Bulk Drug Substance and Drug Product), and ensures Quality Agreements are in place for Clinical Supply. Key member of the Quality Audit Team/partners with GMP Compliance Audit
Provides Quality oversight for all key Quality Systems associated with the development drug candidate including Complaints, Recalls, Field Alerts, Deviations, CAPA, OOS, etc
Ten plus years of hands on CMC Biologics experience within biotherapeutics development/GMP operations. Periods spent in Quality at a Production Center would be considered advantageous
Working knowledge of bulk biologic drug substance (monoclonal antibody, cell drug, etc.) and Parenterals (cold chain liquid/lyophilized form) would be considered an advantage
Strong working knowledge of the cGMPs as it applies to the quality area in Biologics Pharmaceutical Development
Track record of successful Pre Approval Inspections
Recognized as a CMC Biologics expert with an ability to introduce best practices into the quality management systems
Demonstrates ability to resolve complex problems where analysis of complex data and in-depth evaluation of various factors is required
Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment

Director, QA GMP Resume Examples & Samples

Plan, conduct, execute, and follow-up of audits in support of the approved GCA audit plan
Plan, perform and document, as lead or contributing auditor, non-routine audits, verification audits, pre-approval/pre-submission project reviews, “mock” inspections of the various Novartis sites, organizations across all functions, divisions and business units in accordance with the standards defined in the Novartis Quality Manual, the Novartis Audit Manual, and national/international GMP requirements
Perform design review of audited / assessed processes to confirm capability to achieve the desired purpose and compliance with pertaining regulations and Novartis Quality Standards
Ensure appropriate escalation to responsible management in case of critical observations and support immediate follow-up measures according to Novartis Quality Manual
Assess the adequacy and approve, in collaboration with the responsible quality units, proposed corrective/preventative action plans. Verify implementation and effectiveness of CAPAs
Participate in the continuous development of Novartis Quality Manual and Audit Manual based upon subject matter expertise
Provide training on audit techniques across Novartis
Active contributor and participant for the auditor certification program by mentoring and assessing of divisional auditors across the company
Propose GMP topics for lessons learned and best practices to LLN team and contribute to developing these communications
Prepare/contribute to operational team objectives as assigned
Provide guidance for timely remediation and recommendations regarding acceptability of the proposed filing
Participate in remediation or quality upgrade project teams, determine effectiveness of remediation activities and applicability to other divisions, and provide on-going project support and governance, as assigned
Develop and propose remediation plans for global and / or cross-divisional implementation, where identified as a potential systemic gap, for the GMP committee. Propose updates of the Novartis Global Quality Systems, where indicated

Director, QA Technical Testing Resume Examples & Samples

The job entails providing leadership and direction on test data design integration into existing test cases while building an automation testing framework to support all our business partners across the Enterprise
Directs automation resources both onshore and offshore who are responsible for developing automated functional test planning, preparation, execution and metrics reporting for various applications portfolios to formalize the automation model and ensure the proper test environments exist for repeatability of the automation work to continuously add value
Provide consulting and practice leadership in the areas of delivering automation, test data privacy and test metrics solutions to address business challenges and maximize testing efficiencies to increase business value
Advancing the testing practice through innovative ideas using industry standard tools and technology
Provide leadership and direction for methodologies and testing practices for automation, test data design and metrics framework to ensure consistent, efficient, and repeatable solution delivery. Leads QA Metrics collection and monitoring to ensure proper governance and oversight on all key projects and speak to trends to proactively ensure projects remain on track
Participates in Steering Committee meetings and ensure testing voice is heard
Develops blueprints with Architects and Designers to ensure solution has appropriate test environment considerations
Leads all technical initiatives within the Testing CoE to develop a framework that introduces new tools for continuous improvement that Global teams could use to advance the Testing Practice
Leads the design of testing protocols and processes for optimum performance to improve efficiency and reduce costs
Accountable for Technical Testing Delivery - the effective and efficient delivery of all testing work adhering to budget, time and quality standards
Makes recommendations to senior management about the acquisition and/or implementation of software to increase information systems efficiency
Acts as escalation point during early stages of a project to establish plans, standards, and procedures that will add value to projects and satisfy the constraints of the project
Provides technical leadership, mentoring and training to team members
Partners with IT delivery leaders and business account managers to meet/exceed portfolio budget and timeline objectives, being specifically accountable for estimating, developing testing strategies, tracking test planning and execution and implementation validation
Ensures proper entry criteria for the development and maintenance of test environments
Accountable for ensuring vendor solutions for business applications are using proven testing tools and integrates well with our testing practice
Researches emerging trends/best practices and determines implications of proposed methodologies on meeting business unit strategy
Partners with the various Business and Technology teams to make the business unit successful
Provides periodic status reports to senior management, and ensures on time deliverables
Leads planning and estimating of automation activities for large, multi-phase projects and programs
Motivates staff, facilitates teamwork, mentors other managers, attends to morale, and helps resolve personnel problems
Spearheads and guides people through changes
Develops ideas and clearly articulates/presents ideas to senior management
Provides input into cross discipline councils for enhancing or creating new processes or tools to improve our Delivery model across the SDLC
Leads the continuous, measured improvement of testing methodologies, strategies, plans and frameworks
LI-AG1

Associate Director / Director, QA Validation Resume Examples & Samples

Quality oversight of Intarcia’s validated systems
Management of the group of Quality Engineers responsible for review and approval of validation deliverables
Partner on departmental or company-wide projects for systems validation including, but not limited to e-records/e-signature compliance, Electronic Quality Management Systems, Building Automation Systems, Analytical Data Collection Software, Regulatory Information Management Systems and Publishing software, equipment, utilities, facilities, and laboratory systems. This individual will partner with System Owners to ensure compliance of GxP systems lifecycle procedures, tools and methodology
Develops and maintains validation aspects of change control strategies and procedures
Support Compliance activities applicable to country specific regulations (e.g. FDA, Health Canada, EMA), international standards (e.g. MDD, ISO), and other industry standards as appropriate (e.g. GAMP 5)
Assists in the establishment and maintenance of procedures, tools and methodologies to cover all systems lifecycle phases
Advise and consult within Intarcia Therapeutics and with suppliers to facilitate timely and complete resolution to validation issues
Manage or assist with audits of current and prospective suppliers of equipment and software applications and services
Manages and oversees Computerized System processes and procedures for the Quality Assurance group to include, but not limited to CAPA, Non Conformance, and Customer Complaints ensuring focus on meeting Regulatory, compliance and customer requirements
Provide conclusions, recommendations and resulting action plans. Identify and implement appropriate metrics to report and present metrics to review forums as required
Participate in External Audits, and support 3rd party and regulatory authority inspections
Must have the ability to prioritize and manage multiple projects consisting of varying degrees of complexity
A minimum of 12 years System Validation experience in a GMP and/or ISO regulated environment is required
Ten or more years of experience in Compliance, Quality Systems or Quality Assurance within a Biotech, Pharmaceutical, Medical Devices and Diagnostics and other regulated, healthcare industries is preferred
Proficiency using software systems, understanding functionality, and ability to liaise with IT on system enhancements and prioritization and suggest improvements including the ability to translate needs into system requirements is required
Direct experience supervising systems compliance activities in a GMP and/or ISO regulated environment is required
Experience implementing and deploying new processes and systems is required
Project Management experience including leading cross functional projects is required
Excellent Organizational and Communication Skills (written and verbal) is required. Ability to effectively communicate (orally or via written communication) changes, updates, process improvements to the business partners or members of the organization is required
The ability to create plans and reports as it relates to deliverables and validations is preferred. ASQ Certification as a Software Quality Engineer is preferred

Associate Director, QA Site Compliance Resume Examples & Samples

Account for the internal audit/self-assessment program. Ensure that audits are performed per developed schedule. Review findings and makes recommendations for remediation. Ensure timely responses and closure of all action items / commitments
Determine the ability of departments to meet regulatory compliance requirements through the Bayer CMS. Provides QA/regulatory compliance interpretation to department managers and other organization leaders
Provide site leadership for the Quality Management Review (QMR) program. Ensure that all relevant data is presented to Site Leadership. Provide appropriate metrics and trending analyses. Ensure corrective action follow-up
Serve as an organizational leader in preparing for and maintaining standards for regulatory agencies inspections of the Supply Center. Lead the preparation of written, detailed responses in response to on-site or other audits, inspections and surveys
Account for the organization, compilation, editing, and preparation of the annual product reviews and reports with descriptive statistics and data presentation in chart and graphical forms
Provide effective leadership in cGMP compliance related training and developing internal customers/stakeholders on compliance topics
Provide effective personnel leadership including: selecting key personnel and motivating members of the functional area; assisting with Performance Calibration/Talent Pool Management; individual goal setting/performance reviews; managing the development of employees
Identify and evaluate issues of significance, communicating complex issues to quality leadership, providing multiple alternatives to the solution of complex problems and is able to provide guidance in their implementation
Bachelor’s degree in a scientific or technical field, preferably in the biological sciences
10 years of GMP related experience in pharmaceutical, biologics, medical device, or related industry, along with knowledge of applicable US and foreign regulations. At least 4 years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience
Proven ability as a team player and leader
Excellent people skills to convince, motivate, and encourage customers/stakeholders to understand and accept his/her recommendations, especially with borderline issues
Proven ability to express views and opinions, listen well and accept conflicting points of view
Proven ability to lead cross functional teams
The ability to multitask and support changing priorities
Strong written and oral communication skills, good presentation and influencing skills
Ability to assess, investigate and resolve deviations

Director, QA Oversight Resume Examples & Samples

Responsible for successful collection $3+ Billion in billed revenue and manage within budget (~$85M) - (individually – part of the book of business and collectively with the leadership team)
Direct Reports- 5-10 FTEs: Conifer Outsourcing Managers / Analysts
Indirect Reports- Vendor Employees / 1600+ BPO associates
Advanced knowledge of Hospital Revenue Cycle AR, Collections and Vendors
Ability to develop and effectively communicate strategic and tactical plans leading to an efficient and effective outsourcing operations
Supplier Relationships, Contract management and Negotiation skills
Ability to develop, track, trend and analyze Performance metrics, Costs and Benefits
Ability to communicate effectively across levels of an organization as well as external stakeholders and manage relationships across levels
4 year college degree in Business Administration, Finance, or Health Administration or equivalent experience, MBA Preferred
10+ years experience directing a multi-facility healthcare business office or financial services call center
5-10 years of Health Care Vendor experience, preferably Revenue Cycle
5+ years management and development experience in offshore operations preferred
Continuous Improvement or Six Sigma experience desired

Associate Director, QA Validation Resume Examples & Samples

Assesses and interprets FDA and other predicate rules (regulations) and their application to systems within CG&T. Ensure compliance with Federal (FDA, EMA, PMDA), state and local regulations. Ensures and monitor adherence to all company policies and procedures relating to current Good Manufacturing Practices
Drives the development of standard practices to provide oversight to the CG&T Morris Plains site. This includes performing gap analysis of global standards and requirements against site requirements and using the output to support creation or revision of site validation procedures
Collaborate with other functions at the site to develop the Site Validation Master Plan and strategy including the approach to revalidation, defines the validation life cycle approach of the site and the approach towards process validation and equipment qualification
This role is responsible for the review and approval of validation strategies, SOPs, Validation Plans, Validation Protocols, Validation Reports, deviations associated with validation activities and approval of summary reports
Advises and consults for other departments on equipment and computer system validation
Minimally provides input into the audit of vendors, contractors, suppliers and service providers
Provides QA review and approval of Manufacturing, GC, QA, and Facility system change requests to evaluate for validation impact
Provide validation summary information to support assessment of validation status for APQR and Validation lifecycle of equipment and processes
Acts independently to create, implement and maintain up-to-date the site validation compliance program and strategy while providing the necessary training to develop site staff
Perform timely review and revalidation of existing systems to assure Compliance
Collaborate to ensure current industry expectations and standards are met
Perform monitoring of processes and products to identify opportunities for continuous improvement
Needs to be able to manage several interactions and relationships both internal and external and be able to adapt to the changing requirements and needs of the business. Interactions include service providers, vendors, contractors, regulatory agency interactions and interactions with all levels of the organization to establish and drive policies of Novartis while ensuring a pragmatic risk based interpretation of regulations as they apply to Novartis process and operations

Associate Director, QA Resume Examples & Samples

Recommend systems for audit, write systems and procedures audit plans and coordinate scheduling, conduct, reporting and closure of internal systems and procedures audits
Plan,schedule,conduct, report and close audits of clinical research activities in any of the countries involved with corporate contracts
Support director in proposal reviews and reporting QA metrics
Excellent problem solving, risk analysis, and negotiation skills

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