• Develop, maintain and drive compliance of the Affiliate Quality Management Systems
  • Batch release for a temperature sensitive product
  • Management of nonconformities (deviations, change controls, internal and external CAPAs, Quality Events)
  • Ensure local PV related vendors/external partners in the affiliates are qualified
  • Eventually perform batch record reviews and deviation review and approval as a Qualified Person (QP) or on behalf of the QP


  • Bachelor’s degree in Life Sciences - PharmD preferred
  • Minimum of 5 years of relevant experience in QA field with knowledge of GMP/GDP
  • Ability to work as QP (or FvP) in Germany preferred
  • Business fluent in English French and German are an advantage