Director, GMP QA

At Genmab we are dedicated to building extranotordinary 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 and strategically oriented QA Director for Chemical Intermediates (CI) Biological Intermediates (BI) and Drug Substance (DS) to lead Quality Assurance oversight of CI BI and DS activities supporting commercial products all manufactured through external partners.

This role plays a critical part in safeguarding product quality patient safety and supply reliability in a fully outsourced manufacturing addition the role carries responsibility for building and scaling a fit-for-purpose QA organization for CI BI and DS over the coming years aligned with the expansion of Genmabs commercial portfolio and global CMO network.

You will be part of the global GMP QA organization and a key member of the QA leadership team reporting directly to the Team Lead of QA GMP Commercial.

Key Responsibilities

The responsibilities of the QA Director for CI / BI / DS will include but not be limited to:

• Define and drive the QA strategy for CI BI and DS supporting commercial products in a fully outsourced manufacturing model.

• Provide end-to-end QA oversight of commercial CI BI and DS manufacturing activities at CMOs ensuring sustained GMP compliance and supply continuity.

• Hold overall responsibility for QA release of CI BI and DS including establishment of release strategies governance and escalation pathways.

• Ensure robust review and approval of batch documentation and manufacturing data supporting release decisions in accordance with Genmabs Pharmaceutical Quality System.

• Build scale and develop the CI / BI / DS QA organization including defining future capabilities roles and competencies in line with business growth.

• Lead mentor and develop a growing QA team fostering a strong quality culture and ensuring succession and knowledge management.

• Establish and maintain robust quality agreements and governance models with CMOs ensuring clear accountability and escalation pathways.

• Oversee deviations CAPAs change controls and risk assessments related to commercial CI BI and DS manufacturing.

• Ensure QA oversight of continued process verification ongoing validation and lifecycle management for commercial processes.

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

• Plan perform and follow up on audits of CMOs and critical suppliers supporting commercial manufacturing.

• Provide QA input to regulatory submissions variations and post-approval changes related to CI BI and DS.

• Act as a key QA interface to Supply Chain proactively identifying and mitigating quality-related risks to commercial supply.

• Contribute to continuous improvement of Genmabs Pharmaceutical Quality System with focus on commercial operations and outsourced manufacturing.

What We Are Looking For

• You hold a MSc degree in life science.

• Minimum 10 years of experience within the pharmaceutical industry with extensive GMP QA experience supporting commercial CI BI and/or Drug Substance manufacturing at CMOs.

• Proven experience building and scaling QA teams in response to business growth and increasing complexity.

• Strong understanding of biologics manufacturing (e.g. monoclonal antibodies) and associated intermediates; experience with chemical intermediates is an advantage.

• Demonstrated experience with commercial-stage CMO oversight quality agreements audits and regulatory inspections.

• Strong people leadership and organizational design capabilities.

• Solid knowledge of global GMP and ICH requirements and post-approval lifecycle management.

• Comfortable operating in a high-complexity supply-critical environment.

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

What Youll Gain

• A QA leadership role with direct impact on commercial product quality patient safety and supply reliability.

• The opportunity to build and mature a scalable QA organization supporting a growing commercial portfolio.

• A role combining long-term strategic ownership with hands-on engagement in complex supply-critical manufacturing activities.

• A collaborative performance-driven culture that values quality accountability and continuous improvement.

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 youre 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 Genmabs 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 LinkedIn and X.

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