Head of Quality Assurance & FvP (Swiss Responsible Person)

About the role

The company is looking for an experienced Head of Quality Assurance who will also act as the Swiss Fachtechnisch verantwortliche Person (FvP). This senior leader will oversee the Swiss quality function, ensure compliance with Swissmedic, GMP, GDP and narcotics regulations, and drive a strong quality culture across the affiliate.

Key responsibilities

• Lead and develop a team of quality professionals while continuously improving the local Quality Management System (QMS).
• Act as the Swissmedic‑approved FvP, making independent quality decisions, releasing medicinal product batches for the Swiss market and overseeing narcotics handling.
• Drive quality risk management activities, escalate significant risks, and ensure effective CAPA implementation.
• Manage supplier qualification, third‑party logistics, warehouses and distribution centres, and maintain quality agreements.
• Lead Swissmedic inspections, regulatory audits and corporate supplier/service‑provider audits.
• Oversee product complaints, quality defects, recall activities and ensure compliance with storage, transportation and reporting requirements.

Required profile

• University degree in Pharmacy, Life Sciences or a related scientific discipline.
• Eligibility to act as a Swissmedic‑approved FvP.
• Significant experience in pharmaceutical Quality Assurance within Switzerland, including batch certification/release and managing Swissmedic inspections.
• Extensive knowledge of GMP, GDP and Swiss pharmaceutical regulations, as well as narcotics legislation.
• Proven people‑management experience and strong quality risk‑management skills.
• Excellent stakeholder management, high integrity and the ability to balance compliance with business needs.
• Fluent communication in English and German.