Sr Manager, QA GMP

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

Genmab is seeking a Senior Manager for GMP QA Development - Drug Product & Clinical Supply in Denmark to set quality standards for our development products supporting Genmab's clinical pipeline and further development of commercial products.

The GMP QA Senior Manager will join the global GMP QA team, ensuring compliance with industry standards and regulations. This Denmark-based position reports to the Director of GMP QA Development - Drug Product & Clinical Supply. Our Global QA Department has over 50 GXP professionals across Denmark, the Netherlands, the US, Japan, and China.

Candidates should have strong knowledge of GMP guidelines and regulations and be interested in supporting project activities and maintaining compliance.

Key Responsibilities

The main responsibilities of the QA GMP Manager will include, but not be limited to:

• Perform batch review of Drug Product (DP) and IMP (Investigational Medicinal Product).
• Oversee and audit vendors and Contract Manufacturing Organisations (CMOs).
• Support clinical supply manufactured internally at the Genmab Site in Ballerup
• Perform audits of CMOs.
• Be the QA on UAT of IRT systems in collaboration with our digital QA team and the IRT team.
• Be the QA supporting DP, Clinical Supply on development projects.
• Manage deviations, product complaints, CAPAs, and change controls.
• Perform QA tasks relating to project needs, to support batch manufacturing and product release.
• Support audits and regulatory inspections.
• Ensure documentation and process compliance with relevant standards.
• Contribute to updates of the Pharmaceutical Quality System.
• Maintain effective relationships with internal teams and CMOs.
• Coordinate and deliver GMP training.
• Author SOPs and oversee quality-related documentation.
• Maintain compliance throughout development programmes.

• MSc or equivalent in life sciences.
• 5-10 years' pharmaceutical QA experience.
• Experience in DP and IMP for biologics or sterile products, as well as familiarity with QP‑related responsibilities, is considered highly advantageous.
• EDMS proficiency required.
• GMP lead auditor certification preferred.
• Clinical trial development and outsourcing experience desirable.
• Strong English communication and teamwork skills.
• Thrives in a fast-paced, dynamic setting.
• Results-driven and dedicated to Genmab's success.

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs