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Senior Director – Quality Control

Eli Lilly and Company

Katwijk
Full-time
10+ years experience
On-site

Key Skills

Quality Control Strategy
Analytical Governance
cGMP Compliance
Laboratory Operations
Regulatory Inspections
Data Integrity
Strategic Planning
Talent Development
LIMS
ELN
Oral Solid Dosage
API Manufacturing
Executive Leadership
Environmental Health & Safety
Performance Management
Digitalization

Job Description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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 Control is accountable for defining and leading the site Quality Control strategy, ensuring reliable, compliant, and timely analytical testing to support manufacturing, release, and supply commitments. This role provides executive leadership for laboratory operations, analytical governance, and regulatory readiness, while building a high‑performing Quality Control organization aligned with Lilly’s global quality strategy. 

 

Key Responsibilities 

Executive QC Leadership & Governance 

  • Define and own the site Quality Control strategy, ensuring alignment with global quality standards and business objectives 

  • Serve as the senior authority for laboratory operations, analytical governance, and data integrity 

  • Provide executive leadership to ensure scientific excellence, compliance, and continuous improvement 

Laboratory Operations & Analytical Excellence 

  • Ensure Quality Control laboratories deliver accurate, reliable, and timely results to support manufacturing and product release 

  • Establish and oversee analytical governance, metrics, and performance management across all QC operations 

  • Drive standardization, digitalization, and continuous improvement of laboratory systems and processes 

Quality Systems & Regulatory Accountability 

  • Ensure full compliance with cGMPs, regulatory requirements, and laboratory quality systems 

  • Act as a senior QC representative during regulatory inspections and audits 

  • Ensure robust oversight of specifications, methods, reference standards, and documentation 

Leadership, Talent & Organizational Effectiveness 

  • Build, lead, and develop a strong Quality Control leadership team and succession pipeline 

  • Ensure adequate resourcing, capability, and organizational design to support current and future site needs 

  • Foster a culture of accountability, scientific rigor, and quality excellence 

Strategic Planning & Site Partnership 

  • Serve as a senior member of the site leadership community, contributing to site strategy and long-term planning 

  • Partner with Manufacturing, Quality Assurance, Technical Services, and Engineering to enable efficient, compliant operations 

  • Influence enterprise analytical strategy through collaboration with global quality and technical networks 

Environmental Health & Safety 

  • Demonstrate executive accountability for safe laboratory operations and environmental compliance 

  • Ensure strong EHS culture and performance within Quality Control operations 

 

Qualifications and Requirements 

Education 

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

 

Experience 

  • Extensive experience leading Quality Control or laboratory operations in regulated industries 

  • Proven senior‑level accountability for analytical governance, regulatory inspections, and laboratory compliance 

  • 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 establishing or scaling QC laboratory operations in a new or expanding facility is strongly advantageous 

  • Experience with oral solid dosage and/or Active Pharmaceutical Ingredients (API) manufacturing 

Technical & Leadership Expertise 

  • Deep understanding of pharmaceutical laboratory operations, cGMPs, and regulatory expectations 

  • Familiarity with modern analytical techniques and laboratory digitalization platforms (e.g., LIMS, ELN) 

  • Strong executive leadership, communication, and decision-making 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.

Lilly does 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.

#WeAreLilly

Core Responsibilities

Define and lead the site Quality Control strategy to ensure compliant and timely analytical testing for manufacturing and product release. Provide executive leadership for laboratory operations, regulatory readiness, and the development of a high-performing QC organization.

Requirements

Requires a minimum of a Bachelor's degree in a life sciences discipline, with a Master's or PhD strongly preferred. Extensive senior-level experience in QC laboratory operations within regulated industries and familiarity with EMA/FDA inspections is essential.

About Eli Lilly and Company

Industry: Pharmaceutical Manufacturing

Company size: 10,001+ employees

We're a medicine company turning science into healing to make life better for people around the world. It all started nearly 150 years ago with a clear vision from founder Colonel Eli Lilly: "Take what you find here and make it better and better." Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing science to solve some of the world's most significant health challenges. General Information and Guidelines: When you engage with us on LinkedIn, you're agreeing to these Community Guidelines: https://e.lilly/guidelines. If you have questions about a Lilly medicine, contact The Lilly Answers Center at 1-800-Lilly-Rx (1-800-545-5979) Monday through Friday, excluding company holidays.

Added 4 months ago