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.

Maintain, develop, and continuously improve the Global Pharmacovigilance Quality Management System in accordance with applicable GVP regulations, company procedures, and international regulatory requirements. Conduct, coordinate, or oversee outsourced GVP audits and ensure effective management of audit findings through to closure. 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.





Collaborate closely with Global Patient Safety, Regulatory Affairs, Clinical Development, Quality, and external partners to ensure alignment on pharmacovigilance compliance activities. Monitor changes in global pharmacovigilance regulations and ensure timely implementation within the quality system. Provide guidance and training to internal stakeholders on GVP quality requirements, inspection readiness, and quality processes.

Extensive experience in Pharmacovigilance Quality Assurance within a pharmaceutical, biotech, or healthcare environment. Strong knowledge of EU GVP requirements and global pharmacovigilance regulations.

Experience planning, conducting, managing, or overseeing GVP audits and inspection readiness programmes. Comprehensive understanding of pharmacovigilance systems, drug safety processes, quality management systems, and vendor oversight.

Experience managing quality events, CAPAs, risk assessments, compliance metrics, and continuous improvement initiatives. Excellent stakeholder management, communication, and influencing skills within global and cross-functional environments. Strong analytical and problem-solving abilities with a proactive approach to quality and compliance.

Training and experience in Quality Assurance, particularly within Pharmacovigilance, Drug Safety, Clinical Development, or R&D; environments. Professional fluency in English, both written and spoken.

📌 Senior QA Manager GVP (m/f/d) (Barcelona)
🏢 Epm Scientific
📍 Barcelona