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