QA Manager (CSV)

Overview

PM GROUP – Who we are

We are an employee-owned, international project delivery firm with a team of 4,000+ people. We are world leaders in the pharma, food, medtech and mission-critical sectors. From our network of offices in Europe, Asia and the US, we work with the world’s leading organisations, focussing on growing a sustainable business centered around our people, our clients and trade partners.

Our client is a globally active life sciences company, recognized for its high quality standards and strong regulatory track record. Headquartered in Switzerland, the group operates multiple GMP-compliant sites across Europe, the US and Asia.

PM Group is exclusively supporting this client in the search for a QA Manager – Quality Engineering to join their team in the Basel region.

In this key QA position within Quality Engineering, you will ensure GMP compliance of production and analytical systems as well as critical infrastructure, directly supporting product quality, inspection readiness and site growth.

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/reports.
• Author and approve GMP-relevant procedures and records (SOPs, logbooks, forms).
• Act as a QA interface during regulatory inspections and customer audits.
• Maintain and periodically review the GMP status of equipment and facilities, driving continuous compliance.

Qualifications

• 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/validation (QA, C&Q, Engineering or similar).
• Solid hands-on knowledge of facility and equipment qualification in a pharma/biotech or fine-chemicals setting.
• Structured, detail-oriented and solution-focused approach to problem solving and documentation.
• Confident communicator with strong stakeholder management skills; fluent in German and English (written and spoken).