GMP QA Manager
1 month ago
Genmab is seeking a highly skilled GMP QA Manager to join our QA Commercial & Life Cycle team in Denmark. As a key member of our team, you will be responsible for ensuring the quality of our commercial products, collaborating with Contract Manufacturing Organizations (CMOs) and internal process- and QC SMEs.
Key Responsibilities- Maintain and improve Genmab's Pharmaceutical Quality System to ensure compliance with EU and US regulations.
- Stay up-to-date with new and updated GMP/GDP regulations and guidelines.
- Handle deviations, CAPAs, and change control in accordance with Genmab SOPs and applicable regulatory requirements.
- Act as Delegated QP for the release of commercial products.
- Review and author QMS SOPs, Work Instructions, and other documents as needed.
- Support Quality Management Review and Annual Product Review.
- Perform QA activities related to US market release in collaboration with the global QA GMP team, Genmab's CMOs, contract acceptors, and partners.
- Provide QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities, including audits, vendor risk evaluations, and review and negotiation of Quality Agreements.
- Represent QA GMP in project groups to advise on GMP compliance.
- Participate in internal audits and regulatory inspections performed by various Health Authorities.
- Train QA colleagues and stakeholders in relevant GMP topics.
- Promote collaborative relations with internal stakeholders, partners, and CMOs.
- Master's degree or equivalent in a relevant life science subject.
- 5+ years of experience in the pharmaceutical industry within QA.
- Experience with biological and chemical GMP production.
- Experience with CMO collaboration.
- Experience with audits/inspections.
- QP/delegated QP experience.
We are looking for a passionate and dedicated individual who is committed to our purpose of transforming the lives of patients through innovative cancer treatment. You should have excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative attitude. You should also be results and goal-oriented, committed to contributing to the overall success of Genmab.
About GenmabGenmab 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 are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success.
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GMP QA Manager
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Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe 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 pharmaceutical products and processes. This includes maintaining and improving our Pharmaceutical Quality System, handling deviations and CAPAs, and reviewing and authorizing QMS SOPs and other...
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GMP QA Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled GMP QA Manager to join our QA Commercial & Life Cycle team in Denmark. As a key member of our team, you will be responsible for ensuring the quality of our commercial products and maintaining compliance with EU and US regulations.Key ResponsibilitiesMaintain and improve Genmab's Pharmaceutical Quality System...
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