Senior Director – Quality Assurance, Manufacturing

About the role

Eli Lilly is investing €2.6 billion in a new manufacturing facility in Katwijk, Netherlands, producing oral medicines for cardiometabolic health, neuroscience, oncology and immunology. The Senior Director – Quality Assurance, Manufacturing sets and executes the site Quality Assurance strategy, ensures sustained cGMP compliance and regulatory readiness, and acts as a senior member of the site leadership team protecting patient safety and product integrity.

Key responsibilities

• Own the site Quality Assurance strategy aligned with Lilly Global Quality Standards and business objectives, and act as the senior quality authority with final decision-making accountability on quality matters.
• Ensure sustained compliance with cGMPs, regulatory requirements and internal quality systems, and maintain inspection readiness as the primary QA representative during regulatory inspections.
• Oversee governance of deviations, change management, validation, data integrity and CAPA, and engage with the site Works Council on quality-related matters.
• Provide quality oversight for manufacturing processes, facilities, utilities, equipment and computerized systems, and integrate quality into operational excellence and digital manufacturing.
• Build and lead a high-performing QA organization with clear accountability and succession planning, and attract and retain senior quality talent.
• Contribute to site strategy and investment decisions, embed quality in capital projects and site expansion, and collaborate with global and affiliate stakeholders.
• Hold executive accountability for environmental, health and safety standards within the Quality organization.

Required profile

• Master's degree or PhD in Pharmacy, Chemistry, Engineering or a related life sciences discipline preferred; Bachelor's degree minimum.
• Extensive leadership experience in pharmaceutical manufacturing or other highly regulated industries, with proven senior-level accountability for QA, regulatory compliance and inspection management.
• Experience with EMA, FDA or other major regulatory inspections; familiarity with the Dutch regulatory environment and EMA expectations preferred.
• Experience in a greenfield or site start-up environment, and with oral solid dosage and/or API manufacturing.
• Fluency in English required; Dutch strongly preferred.

Required skills

• Deep expertise in cGMPs, quality systems and regulatory expectations.
• Strategic leadership, decision-making and executive communication skills.
• Ability to influence at site, regional and enterprise levels.

What we offer

• Anticipated wage depends on education, experience, skills and location; full-time equivalent employees may be eligible for a company bonus.
• Benefits including pension plan eligibility, vacation benefits, healthcare eligibility, flexible benefits, life insurance and death benefits, time off and leave of absence benefits, and well-being benefits such as an employee assistance program.