Senior Director, Quality Assurance - Global Affiliates

Senior Director, Quality Assurance - Global Affiliates

Genmab

Copenhagen, Denmark

The Role

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.

Responsibilities

Strategic Quality Leadership

• 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.

Quality Oversight & Compliance

• 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.

Quality Leadership Team

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

Quality Systems & Continuous Improvement

• 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.

Leadership & People Development

• Lead and develop a growing, globally distributed QA team, empowering Affiliate leads through accountability, clarity, and a culture of continuous learning;
• Foster a culture of accountability, inclusion, transparency, and collaboration;
• Empower team members with clear roles, responsibilities, and development plans that support Genmab’s long-term quality objectives;
• Promote Genmab’s leadership principles and values of integrity, determination, and teamwork in all QA activities.

Stakeholder Engagement & Collaboration

• Partner with global and regional leaders to ensure quality is embedded across all business functions, and affiliates operate in alignment with Genmab’s quality objectives;
• Partner with functional QA leaders to ensure subject-matter expertise is effectively shared with Genmab Affiliates, and that market-level insights are captured and communicated, ensuring Genmab consistently meets local regulatory requirements;
• Collaborate cross-functionally with Regulatory Affairs, Medical Affairs, and Supply Chain to ensure aligned and compliant processes;
• Represent Genmab QA in external forums and regulatory engagements to promote transparency and regulatory trust;
• Provide senior management with actionable insights through regular quality performance dashboards and risk reviews.

Requirements

• Advanced degree (BSc/MSc/PharmD) in Life Sciences, Pharmacy, or related field required; MBA or equivalent is an advantage;
• Minimum 15 years of experience in Quality Assurance within the biotechnology, pharmaceutical, or related regulated industries, including significant global or regional leadership experience;
• Deep knowledge of GMP, GDP and GVP regulations and major global health authority expectations (EMA, FDA, MHRA, PMDA, Health Canada, etc.);
• Proven success in developing, implementing, and sustaining global QMS frameworks across multiple geographies;
• Demonstrated expertise in audits, inspections, and compliance risk management;
• Experience leveraging digital quality systems, data analytics, and metrics-driven performance management;
• Skilled at leading through influence within complex, matrixed environments. Excellent communication, negotiation, and stakeholder-management skills;
• Fluent in English;
• Strategic and global leadership mindset with a commitment to quality excellence, patient focus, and compliance integrity;
• Strong influencing and relationship management across geographies and cultures;
• Skilled at balancing standardization with local regulatory nuances;
• Decisive, collaborative, and results-oriented;
• Culturally agile and experienced in leading across diverse teams.

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!