EPM Scientific are currently partnered with a global pharmaceutical company dedicated to developing and commercialising innovative therapies across international markets. They are seeking a GVP Quality Assurance Senior Manager to support their Global Pharmacovigilance and Quality function. This is a key role responsible for maintaining and enhancing the Pharmacovigilance Quality Management System, ensuring global regulatory compliance, inspection readiness, and continuous quality improvement across drug safety activities.
Key Responsibilities
Maintain, develop, and continuously improve the Integral Pharmacovigilance Quality Management System in accordance with applicable GVP regulations, company procedures, and international regulatory requirements.
Develop and execute risk-based pharmacovigilance audit programmes covering affiliates, vendors, service providers, business partners, and internal pharmacovigilance processes.
Conduct, coordinate, or oversee outsourced GVP audits and ensure effective management of audit findings through to closure.




Lead inspection readiness activities and support regulatory authority inspections, partner audits, and mock inspections across the pharmacovigilance organisation.
Track, communicate, and escalate significant quality and compliance issues to senior stakeholders while ensuring appropriate corrective and preventive actions are implemented.
Review, author, and approve pharmacovigilance procedures, quality documents, and controlled records to ensure ongoing compliance with global regulations.
Provide quality oversight of outsourced pharmacovigilance activities, including vendor qualification, performance monitoring, and governance activities.
Support pharmacovigilance agreements, due diligence activities, licensing transactions, and business development projects from a quality perspective.
Drive continuous improvement initiatives based on audit outcomes, inspection observations, compliance metrics, and evolving regulatory expectation

📌 Senior QA Manager GVP (Barcelona)
🏢 Epm Scientific
📍 Barcelona