Director of Quality Assurance

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.

As the Director of Quality Assurance, you will be responsible for:

• 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

Required experience for Director of Quality Assurance:

• 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

QA | Quality Assurance | Quality Control | cGMP | AAV Gene Therapy | CDMO | Biologics Manufacturing | Quality Operations | Quality Systems | FDA | CGT | Cell and Gene Therapy