Global GVP Quality Leader | Audits, Compliance & PV

Sobi; Basel; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Sobi is seeking a Global Quality GVP Manager to oversee quality assurance and audits related to GVP activities across global PV operations. The role focuses on developing audit strategies, coordinating PV audits, and ensuring QA involvement in inspections and regulatory interfaces.

The ideal candidate brings extensive pharma GVP experience, strong QA background, and a leadership mindset to drive cross-functional collaboration within the PV and regulatory teams.

Qualifikationen

• University degree in Life Sciences or related discipline.

Aufgaben

• Contribute to the development of the audit strategy & program and plans related to GVP-PV processes.
• Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head.
• Perform and coordinate PV audits internally and externally and act when needed as delegated by Global Quality GCP/GVP Head.
• Support and collaborate with PV organization and safety interfaces (Medical Affairs, Regulatory Affairs, Affiliates).
• Ensure qualification of global and local ESP in GVP area per procedures.
• Act as QA representative in PV inspections and related projects.
• Prepare status reports on audits, audit trending, PV deviations and CAPAs.
• Prepare GVP Audit annual plans per SOPs with risk assessment prioritization.
• Author GVP QA related processes and review PV SOPs.
• Ensure QA qualification of GVP service providers and review PV provisions in contracts/Quality agreements.

Ausbildung

University degree in Life Sciences or related discipline

Jobbeschreibung

Sobi is seeking a Global Quality GVP Manager to oversee quality assurance and audits related to GVP activities across global PV operations. The role focuses on developing audit strategies, coordinating PV audits, and ensuring QA involvement in inspections and regulatory interfaces.

The ideal candidate brings extensive pharma GVP experience, strong QA background, and a leadership mindset to drive cross-functional collaboration within the PV and regulatory teams.