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 Global 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 integral 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 reg

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