Director Quality Assurance - FvP
Core
Establish and maintain the Swiss Quality System and Pharmaceutical Establishment License (PEL) for a biopharmaceutical company, ensuring compliance with Swissmedic and EU GMP/GDP regulations while overseeing global API manufacturing quality.
Role type
Director, Quality Assurance (Swiss FvP)
Builds
Swiss regulatory compliance framework, licensed manufacturing operations, and global API supply chain quality governance.
Domain
Biopharmaceuticals, Regulatory Affairs, Quality Management Systems (QMS)
Deliverable
client delivery
Required skills
Swissmedic regulatory expertise, EU GMP/GDP mastery, Pharmaceutical Establishment License (PEL) management, batch certification/release authority, global API quality governance, supply chain risk management, QMS design and governance, inspection readiness leadership, strategic cross-functional influence.
Preferred skills
Experience standing up a Swiss QMS in a lean/virtual model, experience with external CMO/testing site networks.
Technologies
Swissmedic systems, EU GMP/GDP compliance tools, batch release software, supply chain management platforms.
Responsibilities
Design and maintain the Swiss QMS aligned with Swissmedic and EU standards; lead PEL strategy, submission, defense, and maintenance; serve as primary Swissmedic contact for inspections and regulatory interactions; oversee batch certification/release and product integrity controls; provide global quality oversight for API manufacturing and supply continuity; lead audit execution and CAPA implementation; influence manufacturing footprint and operating model decisions.
Seniority
Director, strategic leadership with hands-on regulatory accountability
