Senior Manager QA Commercial & Cycle – CI, BI & DS; Maternity Cover

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

As part of Genmab's strategy to strengthen end-to-end quality oversight across the supply chain, we are seeking a Senior Manager QA – CI, BI & DS to ensure continued strong GMP quality oversight during a period of parental leave with an expected duration until ultimo January 2027.

The role is based in Denmark and reports to the Director responsible for QA Commercial. You will be part of an experienced and highly skilled QA team responsible for quality oversight of Chemical Intermediates (CI), Biologic Intermediates (BI), and Drug Substance (DS), working closely with CMOs, partners, and internal SMEs.

Key Responsibilities

• Provide GMP QA oversight of CI, BI, and DS manufacturing activities at external CMOs
• Review and approve deviations, CAPAs, change controls, and investigations in accordance with Genmab SOPs and regulatory requirements
• Support batch disposition activities and ensure appropriate quality decisions for CI, BI, and DS including QA review
• Contribute to Product Quality Reviews (PQR/APR) for CI, BI, and DS
• Review, author, and maintain QMS documentation, including SOPs, work instructions, and templates
• Act as QA representative in cross-functional project teams and advise on GMP compliance and regulatory expectations
• Maintain strong collaboration with internal stakeholders, partners, and CMOs to ensure robust and compliant supply chains

Requirements

• Bachelor's or Master's degree in a relevant life science discipline

• Minimum 5 years' experience in the pharmaceutical industry, preferably within QA GMP

• Experience with CI, BI and DS GMP production and delegated QP responsibilities

• Excellent communication and collaboration skills; fluent in English

• Ability to thrive in a fast-paced and changing environment

• Results-oriented and committed to contributing to Genmab's overall success

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing, dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies.

By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit  and follow us on Linked In and X.

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