Global Quality Manager

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Background:

Join IMP Quality Distribution, a critical function within Global Quality Assurance. They are responsible for maintaining the quality and compliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain. The team acts as the appointed Delegate of the Swiss Responsible Person (FvP) and holds Global QA oversight over the entire IMP Distribution Network (Depots) and our key business counterparter, Global Clinical Supply Chain Management Distribution (PTDS-L). They drive continuous improvement and ensure adherence to international GMP/GDP standards.

We are seeking a highly motivated and experienced Global Quality Manager to step into a role of significant reach. This position is instrumental in safeguarding product quality and regulatory compliance for global clinical trials. You will utilize your expertise in quality systems and supply chain distribution knowledge to provide guidance and maintain oversight over complex GxP processes. 

Tasks & Responsibilities:

• Regulatory Compliance: Act as the appointed Delegate of the Swiss Responsible Person (FvP), providing necessary final Quality decision-making
• Global Oversight: Maintain Global QA oversight for the entire Roche IMP Distribution Network and its business counterparter PTDS-L
• Lead the Deviation Management process by performing product quality impact assessments. Provide crucial Quality oversight by reviewing and assessing final evaluations and statements from third parties, ensuring consistency with regulatory standards, and checking if proposed Corrective and Preventive Actions (CAPA) are appropriate
• System Owner: Manage the full lifecycle of quality documentation and Change Records, including establishing, reviewing, and approving critical documents and changes for both internal procedures and external business documents (PTDS-L)
• Inspection Management: Actively drive and support all GxP inspections and audits
• Quality Decision-Making: Manage Temperature Excursion Management for clinical trials, including performing assessments and managing Expert Statements/Opinions
• Support clinical studies by reviewing and approving IMP Supply & Release Flowcharts, Transfer requests, and Expert Opinions
• Establish and approve Master Quality Agreements and Quality Agreements
• Manage Complaint Management for clinical trials within the Roche network
• Support quality-related and business-driven projects within the IMP Distribution network
• Drive continuous improvement activities
• Professional Discipline: Assure GMP/GDP compliance, adhere to Good Documentation Practices (GDP), and ensure training compliance with PQS documents

Must Haves:

• A Bachelor's degree in a relevant scientific or technical field (e.g., Pharmacy, Chemistry, Biology, Engineering)
• Proven and comprehensive experience (min. 3 years) in Quality Assurance with a strong focus on compliance
• Deep knowledge of a regulated GxP environment (GMP/GDP)
• Fluent speaker and writer in English (German is a plus). Fluency is essential for managing critical regulatory documentation, providing authoritative guidance to European sites, and ensuring successful support during Health Authority Inspections

Nice to Have:

• Familiarity with Veeva vault QMS 
• Roche experience
• PTQ experience
• Experience in supplier management especially depots

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining
• Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Marianne Buser.

Basel-Stadt Pharma Aargau Solothurn QMS Quality IMP QA CAPA PTDS GMP GDP Distribution Compliance