Associate Director Clinical QA Compliance ensuring quality and integrity of clinical development activities at BioNTech. Leading the proactive, risk - based Quality Strategy implementation across clinical trials.
About the role
- QA Manager role at Perrigo ensuring product quality through oversight of manufacturing and packaging. Focusing on cross-functional continuous improvement and regulatory compliance in the pharma sector.
Responsibilities
- Ensures that company products meet defined quality standards through Quality management and oversight of the manufacturing, packaging, and QA release teams.
- Promotes development and succession planning for direct and indirect reports within area of responsibility.
- Manages and leads cross functional continuous improvement opportunities and projects.
- Develops and maintains auditing and release procedures which ensure products released for shipment meet company, customer and FDA standards.
- Provides risk assessment over significant Quality events.
- Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality.
- Reviews and approves Standard Operating Procedure updates, change control, and validation reports.
- Leads and guides others in quality driven initiatives in the continuous support of Quality Improvement.
- Final quality approver for standard work instruction (SWI) and standard operating procedures.
- Supports FDA, customer, internal, and other regulatory audits and responses.
Requirements
- Typically a minimum of 8 years in the field and 4 years supervisory experience.
- University Degree or equivalent Bachelor's degree within related discipline required.
- Six or more years’ experience in a regulated industry, pharma preferred.
- Demonstrated ability in areas of people leadership and quality leadership.
- Excellent written and oral communication skills.
Benefits
- We believe our people are our greatest asset.
- Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
- Find out more about Total Rewards at Perrigo.
- We are proud to be included in the Forbes list of "America's Best Employers by State 2024".
- Find out more here
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