Senior Director, Quality Assurance – Global Affiliates

Genmab is seeking a Senior Director, Quality Assurance – Global Affiliates to lead quality governance across its affiliates and partners, ensuring compliance with GxP and GDP regulations. The successful candidate will have experience in developing and implementing global QMS frameworks, leading through influence in complex environments, and driving continuous improvement.

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

Benefits

• Competitive salary and benefits package
• Opportunity to work with a global biotechnology company
• Collaborative and dynamic work environment