Quality Assurance Manager

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're committed to building extraordinary futures together by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.

About Us

We believe in fostering a workplace diversity at all levels of the company and we think it is essential for our continued success. We are an international biotechnology company with a core purpose guiding our unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.

The Role

This position will be part of the well-functioning QA Commercial & Life Cycle team, with responsibility for quality oversight of starting materials, intermediates, and drug substances for commercial products. You will have a close collaboration with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.

Responsibilities
  1. Maintaining and continuously improving Genmab's Pharmaceutical Quality System to ensure compliance with EU and US regulations.
  2. Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines.
  3. Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
  4. Act as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance).
  5. Reviewing and authoring of QMS SOPs, Work Instructions and other documents, as needed.
  6. Supporting Quality Management Review and Annual Product Review.
  7. Performing QA activities in relation to US market release in close cooperation with the global QA GMP team, Genmab's CMOs, contract acceptors and Partners.
  8. Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, and review and negotiation of Quality Agreements.
  9. Representing QA GMP in project groups to advise on GMP compliance.
  10. Participating in internal audits and regulatory inspections performed by various Health Authorities.
  11. Train QA colleagues and stakeholders in relevant GMP topics.


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