GMP Compliance Specialist

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Genmab is an innovative biotech company dedicated to transforming the lives of people with cancer and other serious diseases through cutting-edge antibody medicines.

About the Role

This GMP QA Manager position offers a unique opportunity to contribute to the development and delivery of novel antibody therapies to patients.

Key Responsibilities
  • Ensuring the quality oversight of starting materials, intermediates, and drug substances for commercial products.
  • Collaborating with Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.
  • Maintaining and continuously improving Genmab's Pharmaceutical Quality System to ensure compliance with EU and US regulations.
  • Acting as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance).
  • Supporting Quality Management Review and Annual Product Review.
  • Developing and implementing QA strategies to ensure compliance with GMP/GDP-regulations and guidelines.
About Us

Our commitment to diversity, equity, and inclusion is at the heart of everything we do, and we're passionate about creating a workplace where everyone feels valued and empowered to succeed.



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