Global Quality Manager
Roche Switzerland bridges the gap between pharmaceuticals and diagnostics, housing significant research and development functions. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are seeking a
Global Quality Manager
Background:
Join the IMP Quality Distribution team, a vital function within Global Quality Assurance. This team is responsible for maintaining the quality and compliance of Investigational Medicinal Products (IMP) throughout the clinical supply chain. They act as the appointed Delegate of the Swiss Responsible Person (FvP) and provide Global QA oversight for the entire IMP Distribution Network (Depots), working closely with our key business partner, Global Clinical Supply Chain Management Distribution (PTDS-L). The team drives continuous improvement and ensures adherence to international GMP/GDP standards.
We are looking for a highly motivated and experienced Global Quality Manager to take on a role of significant scope. This position is crucial for safeguarding product quality and regulatory compliance in global clinical trials. You will leverage your expertise in quality systems and supply chain distribution 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 counterpart PTDS-L.
- Deviation Management: Lead the Deviation Management process by performing product quality impact assessments and reviewing final evaluations and statements from third parties, ensuring alignment with regulatory standards and appropriateness of proposed Corrective and Preventive Actions (CAPA).
- System Ownership: Manage the full lifecycle of quality documentation and Change Records, 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 assessments and managing Expert Statements/Opinions.
- Clinical Study Support: Review and approve IMP Supply & Release Flowcharts, Transfer requests, and Expert Opinions.
- Quality Agreement Management: Establish and approve Master Quality Agreements and Quality Agreements.
- Complaint Management: Manage Complaint Management for clinical trials within the Roche network.
- Support Projects: Assist with quality-related and business-driven projects within the IMP Distribution network.
- Continuous Improvement: Drive initiatives to enhance processes and quality standards.
- Professional Discipline: Ensure compliance with GMP/GDP, adhere to Good Documentation Practices (GDP), and maintain 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 experience (minimum 3 years) in Quality Assurance with a strong focus on compliance.
- In-depth knowledge of a regulated GxP environment (GMP/GDP).
- Fluency in English (both spoken and written); German is a plus. Fluency is essential for managing critical regulatory documentation, providing authoritative guidance to European sites, and ensuring effective support during Health Authority Inspections.
Nice to Have:
- Familiarity with Veeva Vault QMS.
- Experience with Roche.
- Experience with PTQ.
- Experience in supplier management, particularly at depots.
What You Will Be Offered:
- An opportunity to work in one of the world's leading pharmaceutical companies.
- A modern campus with ample green spaces and collaborative meeting areas.
- Central location in Basel.
- A diverse job profile.
- Further training opportunities through temptraining.
- Collaboration within a dynamic and motivated team.
If you are interested, please apply online using the form below. Only applications matching the job profile will be considered.