Senior QA Manager GVP (m/f/d)

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 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 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.

#J-18808-Ljbffr