Senior Director, Quality Assurance – Global Affiliates

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!

With a growing network of affiliates and partners across Europe, North America, and Asia-Pacific, Genmab operates within a complex, multi-jurisdictional regulatory environment. This role ensures that our global footprint maintains the highest standards of quality, compliance, and operational excellence.

The Senior Director, Quality Assurance – Global Affiliates plays a pivotal role in leading quality governance across Genmab Affiliates and contributes as a member of the Genmab Quality Leadership Team, shaping our quality strategy.

The Senior Director, QA – Global Affiliates provides strategic leadership and oversight for Quality Assurance across Genmab Affiliates and Partners. This position ensures all Genmab Affiliates and Partners operate with the highest standards of GxP and GDP compliance while driving system maturity, operational consistency, and a culture of proactive quality.

You will lead a growing global team to manage quality risks, advance system maturity through governance and metrics, and partner with senior stakeholders to ensure inspection readiness and continuous improvement across all locations.

Reporting to the Vice President, Global Quality, and serving as a member of the Genmab Quality Leadership Team, this position provides enterprise-level direction for affiliate QA and ensures alignment with Genmab's global quality strategy.

• Lead the strategic execution of quality assurance across Genmab Affiliates, ensuring alignment with corporate quality objectives

• Shape and implement the global affiliate QA strategy with clear performance goals and governance structures

• Collaborate across Global Quality, Regulatory Affairs, Medical Affairs, and Supply Chain to ensure consistency and alignment across quality domains

• Serve as a strategic partner to business and regional leaders, embedding quality considerations into operational and strategic decisions

• Ensure all Genmab Affiliates and third-party entities operate in full compliance with GxP and local health authority regulations, maintaining continuous inspection readiness

• In partnership with functional QA teams, ensure product quality and safety requirements are met across all markets through aligned quality agreements, shared governance, and transparent communication

• Oversee partner and third-party QMS adherence, ensuring external entities performing activities on behalf of Genmab meet company quality standards and procedures

• Establish and chair affiliate QA governance forums to review performance, emerging risks, and compliance trends

• Define and monitor key performance indicators and report regularly to the Quality Leadership Team

• Serve as Genmab's global lead for affiliate audits and inspections, ensuring consistent execution, tracking, and timely closure of findings

• Ensure the Genmab Quality Management System (QMS) is in effective use across all Genmab Affiliates

• Foster a learning organization across Genmab Affiliates by sharing audit insights, regulatory updates, and process improvements

• Lead and develop a growing, globally distributed QA team, empowering Affiliate…