- Leadership of entire QA function including QA Systems, Quality Ops and Validation
- Participation in internal/external audits and ensuring corrective actions
- Leading quality management reviews
- Leading all critical change controls, deviations and CAPA investigations
- Ensuring GMP compliance
- Acting QA SME
- Management of QA budget
- Bachelor's degree in relevant scientific field, advanced degree sought after
- At least 15 years of QA experience in the biopharmaceutical industry
- 10 years in QA leadership
- Cell and Gene Therapy experience is highly sought after
- Expert knowledge of cGMP regulations
- Knowledge of Gene Therapy Manufacturing process within a cleanroom environment
- Experience in successfully leading FDA inspection readiness activities
- Exceptional communication skills oral and written
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Director of Quality Assurance - Boston, United States - Walker Cole International
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1 month ago
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Description
Walker Cole International have been engaged on a confidential search for a Director of Quality Assurance to join a Gene Therapy company based on the East Coast, USA.
Ready to make your application Please do read through the description at least once before clicking on Apply.
As the Director of Quality Assurance, you will be responsible for:
Required experience for Director of Quality Assurance:
QA | Quality Assurance | Quality Control | cGMP | AAV Gene Therapy | CDMO | Biologics Manufacturing | Quality Operations | Quality Systems | FDA | CGT | Cell and Gene Therapy