Director, QA Job Description
Director, QA
provides direction and oversight during active processes and applies understanding of FDA regulations (21 CFR 11, 21 CFR 820), FDA Quality Systems and Continuous improvement.
Director, QA Duties & Responsibilities
To write an effective director, QA job description, begin by listing detailed duties, responsibilities and expectations. We have included director, QA job description templates that you can modify and use.
Sample responsibilities for this position include:
Direct the strategic planning process for EIA globally
Lead definition and tracking of shared goals for EIA
Oversee Cost Management initiatives for EIA
Direct the definition and execution of communication roadmap for EIA
Manage Control Functions Dashboard and Scorecard metrics (Audit Issues, Security Exceptions, Source Code Management)
Lead EIA engagement in key T&O and Enterprise initiatives (examples in Purpose)
Lead the definition of and execution of EIA initiatives to address new compliance or risk requirements or gaps with existing processes (Source Code Mgmt, Server Security Compliance, Integrated IT Portfolio Mgmt, Technology Currency)
Work with HR to lead Talent Management activities for EIA
Standardize our Development and Maintenance work program planning
Identify benchmark metrics and Key performance Indicators (KPI) around Application Development & Maintenance quality and performance
Director, QA Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Director, QA
List any licenses or certifications required by the position: QA, ASQ, ISO, ISTQB, EMS, QMS, CSTE, LEED, RAC, QP
Education for Director, QA
Typically a job would require a certain level of education.
Employers hiring for the director, QA job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Computer Science, Technical, Management, Life Sciences, Education, Chemistry, Biology, Pharmacy
Skills for Director, QA
Desired skills for director, QA include:
Pharmaceutical research and development processes and regulatory environments
Quality assurance processes and procedures
FDA
21 CFR 820 and ASIEN regulatory requirements
ISO13485
Database applications
Spreadsheet
Word-processing
Desired experience for director, QA includes:
Direct the Quality Assurance team to ensure delivery of high quality projects, on time, on budget, with agreed business functionality and benefits
Standardize Quality Assurance metrics and dashboard reporting
Work with Global Resourcing to drive the standardization and effective use of our off-shore partners
Plan and manage capacity, availability, and readiness (full time and across vendors)
Champion strong IT governance and close management of IT Risk including effective identification, remediation and communication of risks
Develop budgetary forecasts and administer actual operating expenses within cost center
Director, QA Examples
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Director, QA Job Description
Job Description Example
Our company is looking for a director, QA. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for director, QA
- Build infrastructure, tool-set and training pipeline to create a consistent approach to QA throughout the tech organization
- Write and execute test plans, file bugs, and communicate with the team about issues
- Expand our end-to-end automated test coverage and build tools to help us test more efficiently
- Interact with users to triage inbound bug reports and reproduce reported issues
- Collaborate effectively with engineering, user ops, and product management teams to identify and resolve high-impact issues
- Responsible for hiring, resource allocation, and budgeting
- Provides direction on supplier capability and quality control plan assessments
- Builds strong productive relationships with suppliers, sourcing, operations and research and development teams to maintain a reliable supplier chain of products, components and services that consistently meet or exceed requirements
- Drives effective and efficient quality techniques such as risk analysis, test method development, design of experiments, statistical analysis, measurement system analysis and development of sampling plans throughout the product life cycle
- Provides leadership in compliance and efficient supplier quality management processes
Qualifications for director, QA
- Experience in managing geographically distributed teams with a minimum team size of 50
- Experience in working in a matrixed environment is required
- An undeniable passion for all things testing related, coupled with a strong sense of ownership to evolve and drive the quality agenda within the organisation
- That they are a forward thinker and a vocal leader who can lead the testing function at a local level and influence the testing agenda at a global level
- Expert knowledge of software quality assurance, testing processes, and methodologies in an AGILE environment
- Strong technical competency and experience in the development of solutions to test both Web and API based applications, utilizing tools such as TestNG, Cucumber and JMeter
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Director, QA Job Description
Job Description Example
Our company is growing rapidly and is hiring for a director, QA. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for director, QA
- As GRM, P&CB’s Operational Risk lead and Operational Risk Council member, you will lead initiatives emanating from Enterprise Risk Management including strategic and tactical initiatives, inclusive of KRI reporting and oversight
- Establishes annual Quality goals and objectives cascaded from the Corporate and site priorities
- Serves as the primary site contact for Regulatory visits such as UK Regulatory agency
- Recruit, mentor, organize, motivate and coach a team of software quality engineering professionals
- Project Sponsor or Business leader for key systems and/or process change projects
- Lead/manage the Returns initiative to minimize returns and improve vendor recovery
- Establish, and maintain the Returns policy and procedures to minimize returns and ensure charges/refunds/vendor recovery is accurate and timely
- Establish SOPs and processes for new programs, and ensure effective ongoing management and visibility as needed
- Continuously review and improve all operational processes
- Lead the merchandise sample organization establishing processes to ensure an efficient flow of samples for all company related needs (styleouts, photoshoots, etc) and ensure sample recovery minimizing loss
Qualifications for director, QA
- Experience with continuous integration and build tools
- Ability to guide teams to executional clarity despite ambiguous and uncertain market inputs and conditions, and manage risk adroitly
- Demonstrated expertise at building high quality products employing high performance teams in the systems, storage or networking areas
- Demonstrated experience in managing sustaining organizations for large enterprise software products
- Excellent verbal and written communications skills, including recommendation and decision-making skills
- Experience in developing, managing, and executing strategy and engineering deliverables
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Director, QA Job Description
Job Description Example
Our company is searching for experienced candidates for the position of director, QA. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, QA
- Work with LAD, OLA, OBL, OMS and OCA Management, Sales, Marketing and Service Departments to plan and schedule product registration and renewal activities and successfully execute against these plans and schedules
- Ensure thorough and effective communication with and work closely with MBCs, and OCA to enable registration and quality matters are addressed appropriately and in a timely fashion
- Establish, implement, monitor and maintain a vigilance process for entire Latin America, Ensures that adverse events and other product quality issues are investigated, documented and reported in a timely manner to local authorities and, whenever appropriate, to OCA RA/QA
- Support ship holds, recalls, corrections and removals whenever needed in the Latin American market
- Maintain awareness of changing regulations and requirements in all Latin American countries
- Provide risk analysis and recommend course of action to deal with changes to the regulatory environment in Latin America
- Interact with distributors, consultants, sanitary health authorities and regulatory bodies throughout the Latin American region on compliance related matters
- Travel, when necessary, to meet with representatives from distributors, consultants, health authorities and regulatory bodies in their home countries
- Ensure LAD, OLA, and OBL and OMS are compliant with internal and external regulatory and quality system requirements
- Provide ongoing analysis on the likely impact of changes to the regulatory environment in Latin America
Qualifications for director, QA
- Strong understanding of distributed file system, analytics, database, and storage technologies
- Ability to use/implement statistical process control and DOE techniques
- Bachelor's Degree in Computer Science (or equivalent technical degree) is required, Masters degree in Engineering or Management a plus
- 10 or more years of working experience in IT industry within Software Development, Test Engineering and Test Automation/tool development for Legacy systems
- 5 years in a Senior Lead/Management role within the Electronic Payment/Financial Services industry
- Extensive experience in development and testing of zOS based applications/systems
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Director, QA Job Description
Job Description Example
Our growing company is looking to fill the role of director, QA. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for director, QA
- Exercise latitude in determining approaches to critical assignments
- Direct projects of critical importance
- Plan, organize, and direct the QA CMO Small Molecule group
- Take the initiative to create and implement a plan to enhance, optimize and improve QA CMO systems
- Represent QA CMO and participate in multi-departmental meetings
- Develop, define, and enforce departmental policies and practices for functional groups
- Facilitate and drive change in a fast paced and “ever changing” environment leveraging his/her strong interpersonal skills
- To represent QA as single point of contact and provides QA guidance for studies in a certain TA or in certain countries
- Leads Significant Quality Issues management for aligned studies, including assessment of potential root causes and remediation (corrective and preventative actions)
- Conducts wide range of GxP (Good Practices Quality Guidelines and Regulations) complex audits, (i.e directed, for-cause) in accordance with QA risk-based processes
Qualifications for director, QA
- Minimum 12 years of experience in combination of hands on individual QA role and leading QA teams
- Knowledge of Data Center and Virtualization will be a strong plus
- Knowledge of Networking will be a strong plus
- 8-10 years of experience leading large scale operational and/or quality improvement initiatives
- Experience with international vendors and customs, shipping, freight
- Experience with product quality standards, systems, processes for a broad range of product categories including hardlines, soft lines and electronics
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Director, QA Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of director, QA. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for director, QA
- Assists with all third party quality systems inspections and audits
- Plan, organize, and direct the functions of QA Validation
- Create a clear vision to build an organization to support the growing validation needs of the company, both locally and globally, both internally and externally
- Take the initiative to create strategic objectives and implement a plan to enhance, optimize and improve QA Validation systems to meet regulatory and corporate needs
- Participate in multi-departmental meetings and project teams, representing functional groups
- Develop global validation policies applicable to multiple sites
- Provide strategic leadership, development and implementation of GxP QA Systems for drug/device combination aseptic products
- Develop and maintain a compliant Quality Management System to comply with applicable company, US and worldwide regulatory requirements including standards, guidance and procedures
- Oversee and manage all aspects of quality systems functions for , Deviations and CAPA, Change Control, Management Review and Product Quality Review, Product Complaints, Risk Management and Failure Analysis, and Validation (facilities, equipment, computer systems and processes)
- Conduct periodic Product Quality and Management Review (quarterly)
Qualifications for director, QA
- Experience with continuous improvement, six sigma or similar methodology
- Experience with product packing standards and optimization
- Proactive change agent who can juggle multiple priorities in a dynamic environment while communicating the company’s vision/mission into effective operational and quality/compliance programs
- A minimum of 10 years’ leadership experience in the medical device industry, with at least 8 years’ experience in regulatory and/or quality function(s) commensurate with responsibilities outlined above
- Experience with multi plant operations with regard to compliance with US Quality System Regulations, ISO 13485, ISO9001, and other Quality System requirements
- Proven audit experience for various regulatory bodies