Global Quality GVP Manager

About the role

The Global Quality GVP Manager will ensure quality oversight and assurance for pharmacovigilance (GVP) activities worldwide, supporting both global and local PV processes at Sobi.

Key responsibilities

• Develop and implement the audit strategy and program for GVP, including PV processes, vendors, partners and affiliates.
• Act as GVP Audit Program Owner and coordinate internal and external PV audits, representing QA during inspections.
• Support the GPV organization and safety interfaces such as Medical Affairs, Regulatory Affairs and affiliates.
• Qualify global and local ESPs in the GVP regulated area according to Sobi procedures.
• Manage end‑to‑end audit processes, prepare status reports, trend analyses and update PSMF information.
• Review and approve PV deviations, CAPAs and related SOPs, ensuring compliance with EU/US/Rest‑of‑World regulations.

Required profile

• University degree in Life Sciences or related discipline.
• Minimum 5 years of pharmaceutical industry experience with GVP responsibilities and audit/QA expertise.
• Strong knowledge of EU, US and global GVP regulations and quality assurance principles.
• Proven ability to work in a structured, results‑oriented manner with high attention to detail.
• Excellent interpersonal and communication skills, with a proactive and collaborative mindset.

Required skills

• GVP regulatory knowledge (EU/US/Rest‑of‑World).
• Audit management and execution.
• Quality assurance systems and SOP development.