Quality Site Head

About the role

This role is accountable for leading quality and compliance oversight across all product lifecycle activities at Lonza Cologne, ensuring full adherence to EU-GMP standards. It oversees both Quality Control and Quality Assurance functions, including product testing, quality systems, and the compliant release of products, while leading and developing a team of up to 12 staff to drive performance and a strong quality culture. The position serves as the site's Quality representative, partnering closely with cross-functional and corporate teams and holding final decision-making authority on product approval or rejection. It also provides leadership and support to Operations and QC teams to address performance and compliance challenges, while maintaining robust quality documentation, guiding site procedures, and ensuring readiness for internal and external audits. This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance A variety of benefits dependant on role and location The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits The full‑time annual base pay for this position in Cologne is expected to range between €90,000 and €126,000. Initial salary placement within this range will be determined based on role‑related factors such as experience, qualifications, and expected contribution.

Responsibilities

• Lead quality and compliance oversight across all site activities, ensuring adherence to EU-GMP and ISO)
• Oversee Quality Control and Quality Assurance functions, including coordination of product testing and final approval or rejection decisions
• Provide strategic quality leadership and expert support to Operations and QC teams to resolve performance and compliance issues
• Act as the site Quality Representative, collaborating with cross-functional teams and corporate quality
• Maintain and improve the site's Quality Management System, including SOPs, processes, and quality documentation
• Ensure audit readiness and support the preparation and execution of internal, external, and regulatory audits.
• Drive quality performance management, including KPIs, management reviews, and continuous improvement initiatives
• Manage quality-related processes such as deviations, CAPAs, change controls, and investigations to ensure timely resolution and compliance.

Requirements

• Extensive experience (10+ years) in Quality, GMP-regulated environments, ideally within biotech, pharmaceuticals, or life sciences.
• Extensive leadership experience in Quality Assurance, Quality Control, and Regulatory Compliance.
• Deep expertise in EU-GMP, ISO 13485 and regulatory frameworks, with strong knowledge of quality systems and compliance requirements.
• Proven leadership capability, including managing teams, driving performance, and influencing cross-functional stakeholders.
• Strong decision-making and accountability, particularly in product release, deviations, CAPAs, and quality risk management.
• Strategic mindset with operational excellence, able to lead audits, drive continuous improvement, and maintain inspection readiness at all times
• About Lonza
• Ready to shape the future of life sciences?

Additional Information

Job Title: Quality Site Head Location: Cologne Relocation support is available for the successful candidate.

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