Senior QA Manager

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 & Department

With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, Genmab recently started to market and sell their own products within cancer treatment. Expanding its focus to also being directly vested in the commercialization of the company’s products, we are now looking to further strengthen the QA Commercial & Life Cycle team located in Denmark and the United States.

As GMP QA Manager you will be a part of the well-functioning QA Commercial & Life Cycle team, with responsibility for quality oversight of Drug Products and Finished Goods for commercial products. You will have a close collaboration with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.  This position will be located in DK, reporting to the Director of QA GMP Commercial & Life Cycle (located in DK).

Responsibilities & Task

• Contribute to review and release (delegated QP) of commercial products, Drug Products and Finished Goods.
• Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
• Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, CPV, and review and negotiation of Quality Agreements.
• Promote collaborative relations with relevant internal stakeholders, partners and CMOs.
• Supporting Quality Management Review and Annual Product Review
• Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with relevant guidelines and regulations.
• Gaining and maintaining knowledge on new/updated GMP regulations and guidelines.
• Reviewing and authoring of QMS SOPs, Work Instructions and template, as needed.
• 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.

Requirements

• You hold a Bachelor/MSc degree or equivalent in a relevant life science subject.
• You have +5 years’ experience within the pharmaceutical industry, preferably within QA GMP/GDP.
• Experience with DP and FG GMP production and delegated QP experience
• Experience with CMO collaboration
• You have excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative mindset.
• As a person you enjoy a fast-paced and changing environment.
• You are results and goal-oriented and committed to contributing to the overall success of Genmab.

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 Genmab.com and follow us on LinkedIn and X.

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