Associate Director, QA GMP

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 QA Associate Director for Chemical Intermediates (CI) Biological Intermediates (BI) and Drug Substance (DS) to direct Quality Assurance oversight of CI BI and DS activities supporting commercial products all manufactured through external addition the role contains Qualified Person (QP) responsibilities for CI BI and DS activities supporting commercial products as reported in the company Manufacturing and Import Authorization (MIA).

This role plays a critical part in safeguarding product quality patient safety and supply reliability in a fully outsourced manufacturing model.

You will be an important part of the global GMP QA organization to ensure compliancewithindustry standards and regulations in relation to commercial CI BI and DS manufacturing. The position willbelocated inDenmarkreporting to the Director of GMP QA Commercial Drug Substance & Intermediate.

Responsibilities

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

• Provide end-to-end QA oversight of commercial CI BI and DS manufacturing activities at CMOs ensuring sustained GMP compliance and supply continuity.
• Ensure batch certification and release within delegated authority in accordance with applicable GMP legislation.
• Ensure batches meet approved Marketing Authorization (MA) requirements prior to certification.
• Maintain independent documented and risk-based decision-making for batch disposition.
• Support regulatory inspections as QP representative when applicable.
• Ensure robust review and approval of batch documentation and manufacturing data supporting release decisions in accordance with Genmabs Pharmaceutical Quality System.
• 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.

Requirements

• You hold a MSc degree (preferably ) or equivalentin 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.
• 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.
• 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 expert role with direct impact on commercial product quality patient safety and supply reliability.
• The opportunity to build and mature a scalable QP setup 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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