At Lilly, we unite caring with discovery to enhance lives globally. As a leading healthcare company based in Indianapolis, Indiana, we strive to deliver life-changing medicines, improve disease management, and contribute to our communities through philanthropy and volunteerism. We are seeking passionate individuals dedicated to making a positive impact on people’s lives.

About the Katwijk Site

Eli Lilly is investing €2.6 billion in a cutting-edge manufacturing facility in Katwijk, Netherlands. This facility will focus on producing oral medications for cardiometabolic health, neuroscience, oncology, and immunology, utilizing advanced manufacturing technologies such as dock-to-dock automation, paperless processes, and process analytical technology, all while achieving carbon neutrality and zero waste to landfills.

The Role

The Senior Director of Quality Assurance, Manufacturing will be responsible for defining and executing the site’s Quality Assurance strategy, ensuring ongoing cGMP compliance, regulatory readiness, and cultivating a robust quality culture within manufacturing operations. This position is a key member of the site leadership team, providing authoritative quality leadership, independent oversight, and enterprise-level influence to safeguard patient safety and maintain product integrity.

Key Responsibilities

• Executive Quality Leadership: Develop and own the site Quality Assurance strategy in alignment with Lilly Global Quality Standards and business objectives. Act as the senior quality authority for manufacturing operations, with ultimate accountability for quality decisions. Serve as a role model for quality culture and patient focus across the site.
• Governance, Compliance & Regulatory Readiness: Ensure continuous compliance with cGMPs, regulatory requirements, and internal quality systems. Maintain inspection readiness and represent Quality Assurance during regulatory inspections. Oversee governance for deviations, change management, validation, data integrity, and CAPA effectiveness. Collaborate with the site Works Council on quality-related matters affecting working conditions.
• Manufacturing & Operational Oversight: Provide strategic quality oversight for manufacturing processes, facilities, utilities, equipment, and computerized systems. Proactively identify, assess, and mitigate quality risks. Integrate quality into operational excellence, digital manufacturing, and continuous improvement initiatives.
• Leadership, Talent & Organization Development: Build and lead a high-performing Quality Assurance organization with clear accountability and succession planning. Ensure quality independence while fostering effective cross-functional collaboration. Attract, develop, and retain senior quality talent to meet long-term site and enterprise needs.
• Strategic Planning & Business Partnership: Contribute to site strategy, investment decisions, and long-term operating models as a core member of the Site Leadership Team. Collaborate with global and affiliate stakeholders to influence enterprise quality strategy. Embed quality considerations in capital projects, technology implementation, and site expansion activities.
• Environmental Health & Safety: Uphold executive accountability for environmental, health, and safety standards within the Quality organization. Ensure safe and compliant operations along with strong EHS performance across manufacturing quality activities.

Qualifications and Requirements

Education: A Master’s degree or PhD in Pharmacy, Chemistry, Engineering, or a related life sciences discipline is preferred; a Bachelor’s degree is the minimum requirement.

Experience: Significant leadership experience in pharmaceutical manufacturing or other highly regulated industries. Proven accountability for Quality Assurance, regulatory compliance, and inspection management at a senior level. Familiarity with EMA, FDA, or other major regulatory inspections is essential, with a preference for knowledge of the Dutch regulatory environment and EMA expectations. Experience in a greenfield or site start-up context, as well as with oral solid dosage and/or Active Pharmaceutical Ingredient (API) manufacturing, is required.

Technical & Leadership Expertise: In-depth knowledge of 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 is required; proficiency in Dutch is strongly preferred.

Lilly is committed to ensuring that individuals with disabilities can actively participate in the workforce and receive equal opportunities in the hiring process. If you need assistance with submitting a resume, please complete the accommodation request form for support. Note that this request is strictly for application process accommodations, and other inquiries will not receive a response.

Lilly is an equal opportunity employer and does not discriminate based on 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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