QA Director Job Description
QA Director Duties & Responsibilities
To write an effective QA director job description, begin by listing detailed duties, responsibilities and expectations. We have included QA director job description templates that you can modify and use.
Sample responsibilities for this position include:
QA Director Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA Director
List any licenses or certifications required by the position: QA, ASQ, ISO, ISTQB, EMS, QMS, CSTE, LEED, RAC, QP
Education for QA Director
Typically a job would require a certain level of education.
Employers hiring for the QA director 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 QA Director
Desired skills for QA director include:
Desired experience for QA director includes:
QA Director Examples
QA Director Job Description
- Directs and oversees the strategic integration and execution of company plan within the medical quality division
- Establishes goals and objectives for division aligned with strategic plans set by top executives
- Oversees product complaint investigations and ensures correction measures are adequate, validated and implemented
- Develops, negotiates and implements quality agreements with other organizations
- Manages facility audits by outside agencies to demonstrate compliance
- Drive innovation and improvement across the QA team and our partner organisations
- Attracts, develops, retains and motivate top software testing talent and automation engineers
- You will assume leadership responsibility for the teams supporting Canadian Banking Quality Assurance (Commercial Portfolio QA Team, Retail Portfolio QA Team)
- You will oversee independent post loan reviews to identify deficiencies and areas of opportunity within adjudication/lending process
- Through feedback to Senior Management, you will be required to impact the appropriateness of credit decisions, adequateness of data integrity and replication of risk ratings
- The ability to facilitate the development of a Continuous Delivery pipeline through the use of automation
- A collaborative approach to partnering with the software development and project management community
- An ability to identify and nurture talent within the CyberSource testing community
- A focus on Team/Service-orientation to promote self-reliance, personal discipline, and empowerment within our talented QA team
- A track record of driving team engagement and delivering on commitments
- A strong academic record (min
QA Director Job Description
- Support activities associated with Vendor Management
- Primary contact for regulatory correspondence with the local district office on quality matters
- Lead investigations pertaining to microbial contamination to assure effective root-cause analysis, corrective action plans determination and remediation plans
- Review and provide strategic support to understanding and managing bioburden trend levels
- Participates in preparation for and execution of regulatory and customer audits
- Develop regulatory strategies and plans to ensure alignment with the business strategy on a country-by-country basis
- Direct and lead regulatory staff in the execution of strategy and regulatory submissions
- Develop and execute outreach strategy to build relationships with distributors, and consultants in order to facilitate interactions on behalf of the Company
- Establish and maintain good relationships and communications with all Regulatory Authorities
- Remain accountable for monitoring and compliance of all regulatory submissions and renewals
- Ability to position and analyze information clearly to help customers make buying decisions
- An excellent understanding about how technology products and solutions solve business problems
- Requires a Bachelor’s Degree in Life Sciences, Engineering, Physical Science or related field
- Extensive knowledge of the Federal Drug Administration regulations, ISO 13485 and Canadian medical device regulation
- Able to make timely critical decisions regarding product quality and or quality system compliance
- Ability to effectively direct teams
QA Director Job Description
- Accountable for being an influencing Leader with external regulators and key industry organizations such as ISPE, PDA and ASQ
- Provides Leadership and collaboration that engenders a culture of cross-site collaboration and fosters a very transparent and respectful approach with regulators in order to advance AZ's influence and reputation
- Own the product delivery process, evolving it as necessary to meet the needs of an agile, high throughput organization
- Manage product requirements and planning
- Create and maintain product delivery timelines and own communication to internal and external stakeholders about milestones and progress
- Manage teams planning and requirements-gathering processes with stakeholders to streamline product delivery
- Act as gatekeeper to help ensure that projects are aligned with overall goals for division
- Own and oversee maintenance of all project documentation, including requirements, product specifications, test plans, and release notes
- Executes other duties as delegated
- Lead, debate, and communicate with key decision makers internally and externally
- A demonstrated ability to manage highly skilled technology teams
- Demonstrate extensive knowledge of assessing risks and recommending risk mitigation
- Progressive career history in the development and implementation of quality systems with oversight of QA, QC, validation, product release, CAPA
- ISO (22000, 9000, 14001, ) or other management system
- SPC software
- 7+ years of experience of web, mobile web, native mobile, connected TV
QA Director Job Description
- Conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders
- Audit preparation and notification to key stakeholders
- Responsible for directing all day to day compliance activities in support of business objectives
- CAPA Process Management
- Management Review and Monthly meetings – Feeder Systems
- Compliance to applicable External standards and worldwide Regulations
- Responsible for assuring the business functions operate in compliance with applicable domestic & international requirements, laws and guidance
- Perform the role of deputy divisional (CS/VI) Management Representative
- Manage departmental costs and spending in support of business objectives
- Provide quality review and approval, as appropriate, for CN’s, protocols , or otherwise directed by the QA Department Head
- Effective communicator across the organization and ability to influence without direct authority to create a culture of quality and operational excellence
- High energy, self-directed and intrinsically motivated to drive results by setting strategic goals, drives aggressive business initiatives that positively represents the brand
- Inspiring leader who communicates passion, energy, and excitement and has high emotional intelligence
- BS Engineering or related discipline
- 10+ years experience in Quality Assurance and Regulatory Affairs of medical products
- Bachelor of Science degree in an engineering, medical, or science discipline required
QA Director Job Description
- Compile, track and trend quality systems metrics and report to management on a quarterly basis (i.e., Lot disposition, Deviations, CAPA, Change Control, Product Complaints, OOS, and Audits) and design action plans to address trends
- Identify, assess and communicate QA strategies, metrics (KPIs), gaps and compliance risks to senior management
- Lead the charter for the selection of an eQMS vendor and implementation
- Partner with Product Development, Regulatory Affairs, Clinical Research, external vendors and partners to support corporate objectives and ensure that the site complies with all quality, regulatory and compliance requirements
- Contribute to site PAI and commercial readiness preparations
- Develop a high performing team to manage GxP QA responsibilities
- Provide training, development and growth opportunities for employees
- ISO Management Representative
- Establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of quality management system and ISO compliance
- Report to top management on the performance of the quality management system and any need for improvement
- Verbal and written Mandarin Chinese is REQUIRED
- Bachelors degree in chemistry, biology, microbiology, industrial pharmacy or other related scientific discipline with a minimum of 7 years experience in QA oversight of pharmaceutical development and manufacturing
- Knowledge of aseptic processing and medical device standards and regulations
- Experience with QA oversight of manufacturing of both Clinical Trial Materials (CTM) and Commercial Products
- Practical knowledge of cGMPs and an ability to apply sound judgment and decision making skills (risk based as appropriate for the phase of clinical development) in order to evaluate product release
- At least 2 years of experience auditing GMP vendors