Global Quality GVP Manager in Basel

Overview

In this role you will oversee quality assurance and GVP-related activities across global PV processes, supporting both global and local PV operations. You will lead audit programs, drive QA integrations in cross-functional PV activities, and ensure inspection readiness. You will collaborate with Medical Affairs, Regulatory, and affiliates to uphold Sobi’s quality standards and risk-based audit strategy. This is an opportunity to shape GVP quality oversight in a fast-growing company focused on rare diseases.

Verantwortungsbereiche

• Develop and maintain the GVP audit strategy and program for PV processes, vendors, and affiliates
• Act as GVP Audit Program Owner when delegated
• Perform and coordinate PV audits (internal and external) and support QA leadership
• Collaborate with GPV organization and safety interfaces (Medical Affairs, Regulatory, Affiliates)
• Ensure qualification of ESPs in the GVP area and participate in PV inspections
• Oversee end-to-end audit management and trend reporting (audits, PV deviations, CAPAs)
• Prepare status reports and metrics for audit oversight and PV quality
• Contribute to GVP SOPs and GVP audit planning with risk assessment and prioritization
• Author and review PV-related SOPs; ensure QA input in contracts/Quality agreements
• Promote Inspection Readiness and a continuous quality mindset across Sobi

Zentrale Anforderungen

• University degree in Life Sciences or related discipline
• At least 5 years of pharmaceutical industry experience with GVP responsibilities and audit/QA exposure
• Expert knowledge of EU/US/RoW GVP regulations and QA principles
• Experience in QA systems and preferably auditing
• Structured, results-focused, detail-oriented
• Strong interpersonal, proactive, collaborative, multi-tasking, and resilient skills

• strong interpersonal skills
• proactive and collaborative mindset
• multi-tasking and resilience
• GVP knowledge
• audit management
• QA systems