QA GMP Manager - Remote within Switzerland

About the role

A late-stage biotech preparing for commercialisation is looking for an experienced QA GMP Manager to join its growing Quality organisation. Working within a lean QA team, the role takes broad ownership of Drug Product manufacturing, clinical and commercial packaging, batch release and external manufacturing oversight. Manufacturing is fully outsourced, so the position works closely with CDMOs, packaging partners, CMC and Global Supply Chain as the company builds its commercial supply network.

Key responsibilities

• Provide QA oversight across Drug Product manufacturing and packaging activities
• Manage quality activities with CDMOs, packaging sites and other external partners
• Support IMP/clinical and commercial batch release activities
• Review and approve batch records, manufacturing documentation, specifications, validation protocols and reports
• Manage deviations, OOS, CAPAs, change controls and other quality records
• Negotiate and maintain Quality Technical Agreements
• Support the qualification and implementation of new manufacturing and packaging partners
• Provide QA input into packaging, process and validation activities
• Support supplier qualification and inspection readiness
• Contribute to the development and improvement of the Pharmaceutical Quality Management System
• Partner with CMC and Global Supply Chain as activities move toward commercial supply

Required profile

• 7+ years of experience in the pharmaceutical industry, including at least 5 years in QA GMP
• Strong experience with Drug Product manufacturing, ideally solid oral dosage forms
• Experience with clinical and/or commercial packaging
• Experience with IMP and/or commercial product release
• Proven experience overseeing CDMOs and outsourced manufacturing partners
• Fluent English; Swiss Responsible Person (RP) qualification or relevant experience is a plus

Required skills

• Strong understanding of GMP, GDP and pharmaceutical quality systems
• Experience reviewing manufacturing, validation and quality documentation
• Ability to make quality risk-based decisions and work independently
• Able to operate across a broad scope within a small, fast-moving organisation