Head of Quality Assurance - QP - #2627065

Summary

Head of Quality Assurance – Qualified Person (QP) role within a newly established contract development and manufacturing (CDMO) operation focused on active pharmaceutical ingredients (APIs) and drug substance production. This is a senior site leadership position responsible for establishing and leading the Quality Assurance function in a new GMP manufacturing environment.

The role sits within the site leadership team and reports directly to the General Manager. It carries responsibility for building a fully compliant, inspection-ready quality system from the ground up, ensuring alignment with EU GMP requirements and applicable regulatory standards. A key focus will be embedding a strong quality culture across the site during its early operational phase, while supporting production scale-up activities.

The Head of QA will lead a small team and act as the central point of accountability for quality oversight across manufacturing operations, regulatory interactions, and customer audits.

This is a site-based role near Frankfurt in Germany requiring regular on-site presence (5 days per week).

Responsibilities

• Lead and develop the Quality Assurance function for a newly commissioned API and drug substance manufacturing site.
• Establish, implement, and continuously improve the Quality Management System (QMS) in line with EU GMP expectations.
• Provide leadership, coaching, and direction to a QA team of approximately five individuals.
• Act as primary quality contact for regulatory inspections, client audits, and internal compliance reviews.
• Oversee batch record review processes and support batch release activities in collaboration with Qualified Person responsibilities where applicable.
• Drive embedding of a strong quality culture across manufacturing and support functions, ensuring compliance and operational discipline.
• Manage core GMP quality systems including deviations, CAPAs, change controls, and quality risk management processes.
• Partner closely with manufacturing, engineering, supply chain, and regulatory teams to ensure GMP compliance is maintained across all operations.
• Support site readiness activities for inspections and customer audits during scale-up and early operations.
• Ensure effective quality oversight of suppliers, contractors, and external service providers.

Requirements

• 8+ years’ experience in Quality Assurance within the pharmaceutical or life sciences industry.
• Strong background working in CDMO or GMP manufacturing environments, ideally within API or drug substance production.
• Proven experience in a leadership role managing QA teams.
• Strong working knowledge of EU GMP regulations and practical application in manufacturing settings.
• Experience supporting regulatory inspections and client-facing quality audits.
• German Qualified Person (QP) status would be advantageous but is not essential.
• Strong leadership capability with a hands-on approach suited to a new site environment.
• Ability to operate effectively in a fast-moving, build-phase manufacturing setting.

If you want to apply

Please submit a CV and a short covering note outlining relevant experience in GMP manufacturing, CDMO environments, and QA leadership roles. Shortlisted candidates will be contacted to discuss the opportunity further.

[email protected]

+441293778666