Quality Assurance Manager - Quality Engineering

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).

Why PM Group?

As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are at the heart of our 2025 business strategy. Click here to read more in our Corporate Responsibility and Health, Safety & Well-being Report.

Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.

PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.

LI-KB1