Senior QA Manager GVP (m/f/d)

EPM Scientific; Cataluña; Presencial; EUR 120.000 - 150.000; Jornada completa

Descripción de la vacante

EPM Scientific is partnered with a global pharmaceutical company seeking a GVP Quality Assurance Senior Manager to support the Global Pharmacovigilance and Quality function. This role focuses on maintaining and enhancing the Pharmacovigilance Quality Management System, ensuring global regulatory compliance and inspection readiness.

You will lead risk-based audit programmes, oversee GVP audits, support regulatory inspections, and drive continuous quality improvement across drug safety processes

Formación

• Extensive experience in Pharmacovigilance Quality Assurance within pharma/biotech environments.
• Strong knowledge of EU GVP requirements and global pharmacovigilance regulations.
• Experience planning, conducting, managing, or overseeing GVP audits and inspection readiness programmes.
• Excellent stakeholder management and communication in global cross-functional settings.
• Proven analytical and problem-solving abilities with proactive quality/compliance focus.

Responsabilidades

• Maintain, develop, and improve the Global Pharmacovigilance Quality Management System.
• Develop and execute risk-based pharmacovigilance audit programmes across affiliates, vendors, and partners.
• Coordinate outsourced GVP audits and manage findings through to closure.
• Lead inspection readiness activities and support inspections and mock audits.
• Review and approve pharmacovigilance procedures and quality documents to ensure compliance.

Conocimientos

Pharmacovigilance QA

GVP regulations

Audit management

Stakeholder management

Analytical skills

QA training

Educación

Pharmacy or related sciences degree

Descripción del empleo

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.