Head of Quality Assurance

Head of Quality Assurance - Clinical Development

Full-time | Permanent | Biotech Sector | Germany

Hybrid: Munich, Germany. (3 days onsite per week)

An innovative biotechnology company is seeking an experienced Head of Quality Assurance to lead all QA activities across clinical development. This strategic, high-impact role oversees the full spectrum of GxP-governed processes, with a primary focus on GMP and GCP , ensuring high product quality, patient safety, and compliance throughout the product lifecycle.

The Role

As the senior QA leader, you will guide the organisation's Quality Strategy, shape the Quality Management System (QMS), and provide oversight across both internal teams and external partners (including CMOs, CDMOs and CROs). You will play a key role in cross-functional decision-making, particularly within CMC, regulatory, and clinical operations.

Key Responsibilities

• Lead and develop the QA department and fully own the company-wide QMS across all GxP areas
• Drive the evaluation and potential implementation of an electronic QMS
• Implement risk-based quality approaches suitable for a fast-growing biotech
• Develop and maintain a quality strategy aligned with international regulatory standards (e.g., ICH Q10, EU GMP, 21 CFR)
• Plan and oversee internal and external audits across GMP, GCP and related areas
• Ensure company-wide inspection readiness
• Contribute to leadership teams, providing expert QA input into clinical, regulatory, and CMC decisions
• Build and maintain a phase-appropriate QMS for a small biotech with outsourced manufacturing
• Foster a strong quality culture grounded in transparency, accountability, and continuous improvement

About You

• Advanced scientific or medical degree (life sciences, pharmacy, medicine)
• 10+ years' experience in pharma / biotech, including 5+ years in Quality Assurance or Compliance
• Strong background in clinical development and GCP expertise
• Proven experience preparing for and managing regulatory inspections
• Deep understanding of global GxP requirements
• Strong leadership skills and experience operating in a matrix environment
• Analytical, solution-oriented mindset
• Fluent English skills; German proficiency is an advantage
• Willingness to travel as required