Head of Quality Assurance

Head of Quality Assurance - Clinical DevelopmentFull-time | Permanent | Biotech Sector | GermanyHybrid: Munich, Germany. (3 days oniste 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 RoleAs 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 ResponsibilitiesLead and develop the QA department and fully own the company-wide QMS across all GxP areasDrive the evaluation and potential implementation of an electronic QMSImplement risk-based quality approaches suitable for a fast-growing biotechDevelop 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 areasEnsure company-wide inspection readinessContribute to leadership teams, providing expert QA input into clinical, regulatory, and CMC decisionsBuild and maintain a phase-appropriate QMS for a small biotech with outsourced manufacturingFoster a strong quality culture grounded in transparency, accountability, and continuous improvementAbout YouAdvanced scientific or medical degree (life sciences, pharmacy, medicine)10+ years’ experience in pharma/biotech, including 5+ years in Quality Assurance or ComplianceStrong background in clinical development and GCP expertiseProven experience preparing for and managing regulatory inspectionsDeep understanding of global GxP requirementsStrong leadership skills and experience operating in a matrix environmentAnalytical, solution-oriented mindsetFluent English skills; German proficiency is an advantageWillingness to travel as required