Associate Director, Team Lead, 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 an experienced QA Associate Director for GMP QA Development - Drug Product (DP) & Clinical Supply to provide strategic and operational QA oversight of development manufacturing activities, primarily performed through external manufacturing partners.

The role is central to ensuring product quality, patient safety, and reliable clinical supply across a fully outsourced development manufacturing network. In close collaboration with CMOs and cross-functional stakeholders, you will help sustain a strong quality culture and ensure compliance with applicable GMP requirements throughout the development lifecycle.

In this role, you will apply your quality and leadership expertise as part of Genmab's global GMP QA organization, supporting development programs and outsourced DP and IMP manufacturing activities.

The position is based in Denmark and reports to the Director of GMP QA Development, Drug Product & Clinical Supply.

Key Responsibilities

The QA Associate Director's responsibilities will include:

• Lead, coach, and develop a team of 5 to drive high performance, engagement, accountability, and professional growth.

• Define team priorities, operational standards, and ways of working that support collaboration, compliance, and inspection readiness.

• Build and maintain strong stakeholder relationships to enable timely, compliant delivery.

• Lead and contribute to cross-functional projects and strategic initiatives within the QA organization.

• Provide end-to-end QA oversight of DP and IMP manufacturing activities, both internally and at CMOs, to ensure sustained GMP compliance and continuity of clinical trial supply.

• Act as QP delegate for DP and IMP activities.

• Ensure independent, documented, risk-based batch disposition decisions and batch release within delegated authority and applicable GMP legislation.

• Oversee deviations, CAPAs, change controls, and risk assessments related to clinical DP, Clinical Supply, manufacturing, and packaging activities.

• Support internally manufactured clinical supply activities at Genmab Site Ballerup.

• Oversee suppliers and Contract Manufacturing Organizations (CMOs), including quality agreements and governance models that ensure clear accountability and escalation pathways.

• Plan, conduct, and follow up on internal audits as well as audits of CMOs and critical suppliers.

• Support audits and regulatory inspections, as applicable.

• Drive inspection readiness and lead QA support for routine and for-cause regulatory inspections at CMOs.

• Provide QA input to regulatory submissions, variations, and development-related changes for Drug Product and Clinical Supply.

• Support continuous improvement of Genmab's Pharmaceutical Quality System.

In this Associate Director role, you will collaborate closely with the GMP QA team, internal stakeholders across CMC, Global Clinical Drug Supply, and Regulatory Affairs, as well as CMOs supporting DP and Clinical Supply activities. The position offers an opportunity to contribute to GMP QA development projects and Genmab's innovative product portfolio, helping advance cancer therapy for patients.

What We Are Looking For

• MSc degree or equivalent qualification in Life Sciences.

• Minimum 10 years of pharmaceutical industry experience, including extensive GMP QA experience supporting clinical Drug Product and IMP activities.

• At least 5 years of leadership experience managing a specialized team.

• Experience as a QP delegate for DP and IMP activities; experience with post-trial access, Named Patient Use, or Access Programs is an advantage.

• Strong understanding of aseptic Drug Product manufacturing, preferably involving monoclonal antibodies or other biologics.

• Solid GMP experience within IMP and Clinical Supply.

• Solid experience with development-stage CMO oversight, quality agreements, audits, and regulatory inspections.

• Excellent English communication skills and a pragmatic, risk-based QA mindset.

• A positive, collaborative mindset with the ability to thrive in an ambitious, dynamic environment characterized by change and continuous development.

What You'll Gain

• A QA leadership role with direct accountability for the quality and release of clinical Drug Product and Clinical Supply.

• A key position in a growing, highly collaborative QA organization with broad cross-functional exposure.

• A role that combines long-term strategic ownership with hands-on QA decision-making in complex, supply-critical DP and Clinical Supply operations.

• The opportunity to support innovative biologics and development programs that can make a meaningful difference for patients.

• Close collaboration with experienced colleagues, CMOs, and global stakeholders across the value chain.

• A dynamic, international work environment built on professionalism, trust, and continuous development.

• The chance to influence processes, drive quality improvements, and help shape ways of working in an evolving organization.

• A culture that values teamwork, knowledge sharing, and a positive environment where people support each other and succeed together.

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.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Client-provided location(s): Copenhagen, Denmark

Job ID: Genmab-52368421

Employment Type: FULL_TIME

Posted: 2026-06-13T19:22:41