Senior Director - Quality Assurance, Manufacturing

Senior Director - Quality Assurance, Manufacturing

Eli Lilly Benelux

Katwijk, Netherlands

Position Overview

The Senior Director – Quality Assurance, Manufacturing is accountable for setting and executing the site Quality Assurance strategy, ensuring sustained cGMP compliance, regulatory readiness, and a strong quality culture across manufacturing operations. This role serves as a senior member of the site leadership team, providing decisive quality leadership, independent oversight, and enterprise‑level influence to protect patient safety and product integrity.

Key Responsibilities

Executive Quality Leadership

• Define and own the site Quality Assurance strategy aligned with Lilly Global Quality Standards and business objectives.
• Serve as the senior quality authority for manufacturing operations, with final decision‑making accountability on quality matters.
• Act as a visible role model for quality culture, integrity, and patient focus across the site.

Governance, Compliance & Regulatory Readiness

• Ensure sustained compliance with cGMPs, regulatory requirements, and internal quality systems.
• Maintain continuous inspection readiness and act as the primary Quality Assurance representative during regulatory inspections.
• Establish and oversee robust governance for deviations, change management, validation, data integrity, and CAPA effectiveness.
• Engage constructively with the site Works Council (ondernemingsraad) on quality-related matters affecting working conditions.

Manufacturing & Operational Oversight

• Provide strategic quality oversight for manufacturing processes, facilities, utilities, equipment, and computerized systems.
• Ensure quality risks are proactively identified, assessed, and mitigated.
• Drive integration of quality into operational excellence, digital manufacturing, and continuous improvement initiatives.

Leadership, Talent & Organization Development

• Build, lead, and develop a high‑performing Quality Assurance organization with clear accountability and succession planning.
• Ensure quality independence while enabling effective cross‑functional collaboration.
• Attract, develop, and retain senior quality talent to support long‑term site and enterprise needs.

Strategic Planning & Business Partnership

• Serve as a core member of the Site Leadership Team, contributing to site strategy, investment decisions, and long‑term operating model.
• Influence enterprise quality strategy through collaboration with global and affiliate stakeholders.
• Ensure quality considerations are embedded in capital projects, technology implementation, and site expansion activities.

Environmental Health & Safety

• Demonstrate executive accountability for environmental, health, and safety standards within the Quality organization.
• Ensure safe, compliant operations and strong EHS performance across manufacturing quality activities.

Qualifications and Requirements

Education

• Master's degree or PhD in Pharmacy, Chemistry, Engineering, or a related life sciences discipline preferred; Bachelor's degree minimum.

Experience

• Extensive leadership experience within pharmaceutical manufacturing or other highly regulated industries.
• Proven senior‑level accountability for Quality Assurance, regulatory compliance, and inspection management.
• Experience with EMA, FDA, or other major regulatory inspections (given the new facility context). Familiarity with Dutch regulatory environment and EMA expectations is preferred.
• Experience in a greenfield or site start-up environment.
• Experience with oral solid dosage and/or Active Pharmaceutical Ingredient (API) manufacturing.

Technical & Leadership Expertise

• Deep expertise in cGMPs, quality systems, and regulatory expectations.
• Strong strategic leadership, decision‑making, and executive communication skills.
• Ability to influence at site, regional, and enterprise levels
• Fluency in English required; Dutch language proficiency strongly preferred.