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 general 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 expectations.
- 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.

Requirements

- Degree in Pharmacy, Life Sciences, Biology, Chemistry, Medicine, or a related scientific discipline.
- 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.
- Knowledge of related GxP areas, including GCP and GMP, and their interfaces with pharmacovigilance activities.
- 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.
- Previous experience supporting regulatory inspections and health authority interactions is highly desirable.
- 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.

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