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GMP QA Manager
2 months ago
About the Role
We are seeking a highly skilled GMP QA Manager to join our team at Genmab. As a GMP QA Manager, you will be responsible for ensuring the quality of our commercial products, including starting materials, intermediates, and drug substances. You will work closely with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.
Key Responsibilities
- Maintaining and continuously improving Genmab's Pharmaceutical Quality System to ensure compliance with EU and US regulations.
- Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines.
- Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
- Act as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance).
- Reviewing and authoring of QMS SOPs, Work Instructions and other documents, as needed.
- Supporting Quality Management Review and Annual Product Review.
- 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.
- 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.
- Representing QA GMP in project groups to advise on GMP compliance.
- Participating in internal audits and regulatory inspections performed by various Health Authorities.
- Train QA colleagues and stakeholders in relevant GMP topics.
- Promote collaborative relations with relevant internal stakeholders, partners and CMOs.
About You
- You hold a Master's degree or equivalent in a relevant life science subject.
- You have 5+ years experience within the pharmaceutical industry within QA.
- Experience with biological and chemical GMP production.
- Experience with CMO collaboration.
- Experience with audits/inspections.
- QP/delegated QP experience.
What We Offer
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. We offer a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are passionate about quality and committed to excellence, we encourage you to apply for this exciting opportunity.
