Senior Biotechnology QA Manager
4 weeks ago
At Genmab, we are seeking a highly skilled and experienced Senior Biotechnology QA Manager to join our team in Copenhagen. This is an excellent opportunity for a results-driven professional to take on a challenging role and contribute to the success of our organization.
This position will report directly to the Director of QA GMP Commercial & Life Cycle and will be responsible for ensuring compliance with EU and US regulations. The successful candidate will have a strong background in pharmaceutical quality assurance and experience in managing GMP/GDP-regulated environments.
Main Responsibilities- Maintain and continuously improve Genmab's Pharmaceutical Quality System (PQS) to ensure compliance with relevant regulations and guidelines.
- Stay up-to-date with new/updated GMP/GDP regulations and guidelines, and implement necessary changes to PQS.
- Manage deviations, CAPAs, and change control in accordance with Genmab SOPs and applicable regulatory requirements.
- Act as delegated QP for the release of commercial products, including biological intermediates, chemical intermediates, and drug substances.
- 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 Contract Manufacturing Organizations (CMOs), contract acceptors, and partners.
- Provide QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities, including audits, vendor risk evaluations, 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.
We are looking for a highly motivated and organized individual with a strong background in pharmaceutical quality assurance. The ideal candidate will have:
- A Master's degree or equivalent in a relevant life science subject.
- 5+ years of experience within the pharmaceutical industry in QA.
- Experience with biological and chemical GMP production.
- Experience with CMO collaboration.
- Experience with audits/inspections.
- QP/delegated QP experience.
The successful candidate will also possess excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative attitude.
About GenmabGenmab is an international biotechnology company committed to improving the lives of patients through innovative antibody therapeutics. Our team is passionate about developing next-generation antibody technology platforms and leveraging translational research and data sciences to bring new treatments to market.
Why Join Us?As a Senior Biotechnology QA Manager at Genmab, you will have the opportunity to work with a talented team of professionals who are dedicated to making a difference in the lives of patients. You will be responsible for ensuring compliance with regulations and guidelines, and contributing to the success of our organization.
We offer a competitive salary package, including an estimated salary of €95,000 - €110,000 per year, depending on qualifications and experience.
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