Senior Director – Quality Assurance, Manufacturing

Eli Lilly and Company; Katwijk; On-site; EUR 160,000 - 210,000; Full time

Job summary

Eli Lilly and Company in Katwijk seeks a Senior Director – Quality Assurance, Manufacturing to set and drive the site QA strategy, ensure sustained cGMP compliance, and maintain regulatory readiness across manufacturing operations.

As a member of the site leadership team, you will act as the senior quality authority, lead a high‑performing QA organization, and partner with global stakeholders to protect patient safety and product integrity.

Qualifications

• Deep expertise in cGMPs, quality systems, and regulatory expectations.
• Proven senior-level accountability for QA, regulatory compliance and inspections.
• Experience with EMA/FDA inspections and start-up environments.

Responsibilities

• Define and own the site QA strategy aligned with Lilly Quality Standards.
• Serve as the senior quality authority for manufacturing operations.
• Maintain inspection readiness and lead regulatory inspections.
• Oversee governance for deviations, change control, validation, data integrity, CAPA.
• Drive quality integration with operations, digital manufacturing and continuous improvement.
• Lead the QA organization with accountability and succession planning.

Skills

QA leadership

Regulatory inspections

cGMP expertise

Executive communication

Site leadership

Quality systems

Strategic decision-making

Education

Master/PhD in life sciences or related field

Bachelor’s degree

Job description

About the Katwijk Site

Eli Lilly is investing €2.6 billion in a new state‑of‑the‑art manufacturing facility in Katwijk, Netherlands. This facility will produce oral medicines for cardiometabolic health, neuroscience, oncology, and immunology, incorporating next‑generation manufacturing technologies including dock‑to‑dock automation, paperless manufacturing, and process analytical technology while achieving carbon neutrality and zero waste to landfills.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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