Global Quality Manager - IMP Distribution (QA)

About the role

Roche's IMP Quality Distribution, part of Global Quality Assurance, maintains the quality and compliance of Investigational Medicinal Products (IMP) across 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
• Lead deviation management through product quality impact assessments and review third-party evaluations and CAPA proposals
• Manage the full lifecycle of quality documentation and change records, including approval of internal and external 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 clinical trial complaints
• Drive network improvement projects while adhering to 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 (e.g. Pharmacy, Chemistry, Biology, Engineering)
• Fluent German and English, needed for regulatory documentation, guidance to European sites and health authority inspections