Global Quality GVP Manager

Global Quality GVP Manager

Sobi

Stockholm or Basel, Switzerland

Job Description

In this pivotal position, you will ensure quality oversight and assurance across our global pharmacovigilance (PV) activities. You will guide and support both global and local PV initiatives, contribute to the development of audit strategies and plans, and act as a key partner in cross-functional projects. Your work will involve collaborating with stakeholders across the Sobi organization, supporting the qualification of service providers, and representing quality assurance during inspections and audits. Based at our Global Headquarters in Stockholm or our hub in Basel, you will report directly to the Senior Director, Head of GCP/GVP Global Quality.

This position is based at our Global Headquarters in Stockholm, Sweden or Global hub in Basel, Switzerland, reporting directly to Sr Director, Head of GCP/GVP Global Quality GCP/GVP

Key Responsibilities

• Ensuring quality oversight and quality assurance activities related to GVP area;
• Guide and support from a quality perspective the global and local, as applicable, PV activities within Sobi;
• Contribute to the development of the audit strategy& program and plans related to the GVP area-PV processes, vendors, Partners and affiliates;
• Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head;
• Support the Global GPV organization in their PV QMS related activities and local ones, as applicable;
• Perform and coordinate PV audits internally and externally and act whenever needed as delegated by Global Quality GCP/GVP Head;
• Support and collaborate with GPV organization and the safety interfaces such as Medical Affairs, Regulatory Affairs and Affiliates, as applicable;
• Ensure qualification of global and local ESP, as applicable in GVP regulated area per Sobi procedures;
• Act as QA representative in PV Inspections and different initiatives or projects as needed.

Qualifications

About you

You are a structured, results-oriented professional who thrives in a dynamic, fast-paced environment. Your strong interpersonal skills and flexible, communicative approach make you a valued collaborator. You are proactive, resilient under pressure, and adept at multitasking. Most importantly, you are passionate about making a positive impact for patients and are eager to contribute to Sobi’s mission and values.

Key Qualifications

• University degree in Life Sciences or related field;
• Minimum 5 years’ experience in the pharmaceutical industry with GVP responsibilities;
• Proven experience in audit management and/or quality assurance;
• Strong knowledge of EU/US/Rest of World GVP regulations;
• Experience with QA systems and auditing is highly valued.