Global GVP Quality & Audit Leader

Sobi - Swedish Orphan Biovitrum AB (publ); Basel; Vor Ort; CHF 120.000 - 190.000; Vollzeit

Zusammenfassung

Sobi is seeking a Global Quality GVP Manager to provide quality oversight and assurance for GVP activities. You will guide PV-related QA within Sobi, supporting both global and local PV processes.

Responsibilities include leading the GVP audit program, coordinating audits, and collaborating with Medical Affairs, Regulatory Affairs, and affiliates to ensure QA excellence across GVP activities.

Qualifikationen

• GVP quality oversight experience required.
• Audit program ownership and coordination.
• Strong QA principles and regulatory understanding.
• Experience with PV processes and safety interfaces.
• Proactive, collaborative, results-driven mindset.

Aufgaben

• Contribute to GVP audit strategy and program.
• Act as GVP Audit Program Owner when delegated.
• Coordinate PV audits internally and externally.
• Support GPV organization and safety interfaces.
• Ensure qualification of ESP per GVP procedures.
• Represent QA in PV inspections and projects.
• Maintain end-to-end audit management and metrics.
• Assess PV deviations and CAPAs from QA perspective.
• Update PSMF with audit information and metrics.
• Develop GVP audit annual plans with GPV team.
• Author and review PV-related SOPs and QA processes.
• Collaborate with procurement and business for GVP supplier QA.

Kenntnisse

GVP Audits

Audit management

Quality Assurance

Regulatory knowledge

Cross-functional

Ausbildung

University degree in Life Sciences

Jobbeschreibung

Sobi is seeking a Global Quality GVP Manager to provide quality oversight and assurance for GVP activities. You will guide PV-related QA within Sobi, supporting both global and local PV processes.

Responsibilities include leading the GVP audit program, coordinating audits, and collaborating with Medical Affairs, Regulatory Affairs, and affiliates to ensure QA excellence across GVP activities.