Global Quality GVP Manager

Sobi seeks a Global Quality GVP Manager in Basel to oversee quality assurance for pharmacovigilance activities, manage audits, and ensure regulatory compliance across global operations.

This position is responsible for providing quality oversight and assurance within the Global Pharmacovigilance (GVP) framework. The role guides and supports both global and local PV activities, ensuring that all processes meet rigorous quality standards and regulatory requirements.

Responsibilities

• Develop and maintain the audit strategy, program, and plans for GVP-related PV processes, vendors, partners, and affiliates.
• Serve as the GVP Audit Program Owner when assigned by the Global Quality GCP/GVP Head.
• Execute and coordinate internal and external PV audits, acting on behalf of the Global Quality GCP/GVP Head as needed.
• Collaborate with the GPV organization and safety interfaces, including Medical Affairs, Regulatory Affairs, and local affiliates.
• Qualify global and local Electronic Safety Platforms (ESP) within GVP-regulated areas according to company procedures.
• Represent Quality Assurance during PV inspections and various projects or initiatives.
• Manage the end-to-end audit process, ensuring excellence in audit management and providing oversight of assigned audits.
• Assess and approve PV deviations and related Corrective and Preventive Actions (CAPAs) from a quality perspective.
• Prepare regular status reports on audit performance, PV deviation trends, CAPA progress, and agreed-upon metrics.
• Update the Periodic Safety Update Report (PSMF) with audit-related information and participate in QPPV extended meetings.
• Create annual GVP audit plans based on SOPs, ensuring risk assessment and prioritization are done in collaboration with the GPV organization.
• Author GVP QA processes and review or approve PV-related SOPs, including those from other RDMA and Quality areas with PV interfaces.
• Contribute to cross-functional teams with procurement and business owners to define GVP requirements and qualify GVP service providers.
• Promote inspection readiness and a continuous quality mindset across the organization as a QA representative during partner audits.

Requirements

• University degree in Life Sciences or a related field.
• Minimum of five years of experience in the pharmaceutical industry with GVP responsibilities, audit management, and/or Quality Assurance.
• Deep knowledge of EU, US, and Rest of World GVP regulations, as well as Quality Assurance principles.
• Documented education or experience in QA systems, with a preference for auditing experience.
• Structured approach with a strong focus on results and high attention to detail.
• Strong interpersonal skills, with a communicative and flexible attitude.
• Proactive and collaborative mindset, with strong multi-tasking abilities, resilience, and adaptability.

Nice to have

• Prior experience in auditing.

What the company offers

• A workplace committed to inclusivity, sustainability, and flexibility that fosters professional growth and development.

About the company

Sobi is a diverse team of entrepreneurial individuals passionate about transforming the lives of people living with rare diseases. The company is driven by a growth journey toward becoming a global leader, moving quickly and challenging the status quo to redefine standards of care.

• Core values include Ambition, Ownership, Urgency, Partnership, and Care.
• The team is dedicated to making a meaningful difference for rare disease patients.
• The culture encourages challenging the status quo and moving quickly to achieve goals.