Director of Quality Assurance

  • USD $200,000.00
  • MA, US
  • Permanent

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

Lauren McQuade Director - Global Contract US & International

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