Global Quality Manager (QA Manager) - IMP Distribution

About the role

Roche's IMP Quality Distribution, part of Global Quality Assurance, maintains the quality and compliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain and acts as the appointed Delegate of the Swiss Responsible Person (FvP). The company is looking for an experienced Global Quality Manager to safeguard product quality and regulatory compliance for global clinical trials, overseeing complex GxP processes.

Key responsibilities

• Act as the appointed Delegate of the Swiss Responsible Person (FvP) and make final quality decisions
• Maintain Global QA oversight of the IMP Distribution Network and PTDS-L, and lead deviation management with product quality impact assessments
• Review third-party evaluations and statements and check that proposed CAPAs are appropriate
• Manage the full lifecycle of quality documentation and change records, including approval of internal procedures and external business documents
• Drive and support GxP inspections and audits
• Manage temperature excursion management for clinical trials, including assessments and expert statements
• Review and approve IMP supply flowcharts, transfer requests, quality agreements and manage clinical trial complaints
• Lead network improvement projects while ensuring GMP/GDP, Good Documentation Practices and PQS training compliance

Required profile

• Proven, comprehensive experience in Quality Assurance with a strong focus on compliance
• Deep knowledge of a regulated GxP environment (GMP/GDP)
• Bachelor's degree in a relevant scientific or technical field such as Pharmacy, Chemistry, Biology or Engineering
• Fluent German and English, needed for regulatory documentation, guidance to European sites and support during health authority inspections