Global Quality Manager

Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailored solutions in personnel consulting.
For our client Roche in Basel , we are looking for a reliable and motivated (m/f/d).
Global Quality Manager

• Start Date:
• Latest Possible
  
  Start Date:
• Planned Duration of Employment: 1 year
• Extension: very likely
• Workplace:
  Basel
• Workload: 100%
• Home Office: 60% at the office and 40% HO

• 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).

• 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

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