QA GMP Manager

QA GMP Manager

Remote within Switzerland l Full-time l Permanent contract

We are supporting a late-stage biotech preparing for commercialisation in the search for an experienced QA GMP Manager to join its growing Quality organisation.
Working within a lean QA team, this person will take broad ownership across Drug Product manufacturing, clinical and commercial packaging, batch release and external manufacturing oversight. With manufacturing fully outsourced, the role will work closely with CDMOs, packaging partners, CMC and Global Supply Chain as the company continues to build its commercial supply network.

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 continued development and improvement of the Pharmaceutical Quality Management System
• Partner closely with CMC and Global Supply Chain as activities transition towards commercial supply

Requirements

• 7+ years of experience within the pharmaceutical industry, including at least 5 years within 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
• Strong understanding of GMP, GDP and pharmaceutical quality systems
• Proven experience overseeing CDMOs and outsourced manufacturing partners
• Experience reviewing manufacturing, validation and quality documentation
• Comfortable making quality risk-based decisions and working independently
• Able to operate across a broad scope within a small, fast-moving organisation
• Fluent English

Nice to Have

• Swiss Responsible Person (RP) qualification or relevant experience
• Experience supporting products from development through commercialisation
• Commercial launch/readiness experience
• New vendor or manufacturing/packaging site implementation
• Process improvement or process mapping experience
• Drug Substance exposure