QA Manager - Quality Engineering (Basel Region)

About the role

PM Group, an employee-owned international project delivery firm, is recruiting a QA Manager (Quality Engineering) for a globally active life sciences client headquartered in Switzerland. The client operates multiple GMP-compliant sites across Europe, the US and Asia. The role ensures GMP compliance of production and analytical systems and critical infrastructure, supporting product quality, inspection readiness and site growth.

Key responsibilities

• Own the GMP-compliant life cycle of manufacturing and analytical systems and related infrastructure.
• Review, challenge and approve requalifications, maintenance plans, technical changes and deviations.
• Provide technical QA leadership for qualification and validation workstreams in projects, including CAPEX.
• Assess and approve qualification documentation (URS, DQ, IQ, OQ, PQ) and higher-level validation plans and reports.
• Author and approve GMP-relevant procedures and records (SOPs, logbooks, forms).
• Act as QA interface during regulatory inspections and customer audits.
• Maintain and periodically review the GMP status of equipment and facilities.

Required profile

• University degree (Master's preferred) in Engineering, Chemistry, Process/Pharmaceutical Sciences or a related discipline.
• 5+ years of experience in a cGMP environment with a strong focus on qualification and validation (QA, C&Q, Engineering or similar).
• Solid hands-on knowledge of facility and equipment qualification in a pharma/biotech or fine-chemicals setting.
• Fluent in German and English, written and spoken.