Quality Assurance Director for Pharmacovigilance
4 days ago
About Us
Kyowa Kirin International (KKI) is a leading pharmaceutical company dedicated to making people smile. Our purpose goes beyond drug discovery and development; we strive to embed care into everything we do, making a difference every day for those who need it most. As an inclusive organization, we take the time to understand what matters to our patients, their families, and healthcare professionals, enabling us to deliver life-changing solutions sooner. Our culture is built on values: Teamwork, Commitment to Life, Innovation, and Integrity, which empower us to push boundaries and create extraordinary impact.
Job Summary
We are seeking a highly skilled Quality Assurance Director for Pharmacovigilance to lead our Global Pharmacovigilance Audit Strategy and Schedule. This role requires close collaboration with the Global Head of GxP Inspections & GVP Quality, maintaining risk standards, methodologies, and best practices to ensure consistency. Additional responsibilities include supporting the continuous improvement of Kyowa Kirin's Quality System, PV inspections, regulatory intelligence activities, SOP and WI management, and project liaison activities.
Key Responsibilities:
- Global Pharmacovigilance Audits: Plan, conduct, and support internal and external GVP audits, follow-up on corrective actions, maintain oversight of audits in eQMS, contribute to auditing process improvement, and delegate responsibilities as assigned.
- Line Management: Manage a team of 5 staff, including delegation of tasks and ensuring adequate oversight.
- Quality Management System: Lead collaboration with Functional Area Heads, Regional Quality Leads, and foster a continuous improvement mentality within Kyowa Kirin. Ensure the establishment and maintenance of Quality Documentation, identify process gaps, and collaborate with other departments for resolution.
- Inspections and Health Authority Inspection Management: Lead the support of GVP/GCP inspections, QC of responses to Regulatory Authorities, supervise corrective actions, and maintain awareness of GVP inspections, findings, and corrective actions.
- Project Liaison: Provide sound advice on GxP guidelines and regulations, quality-related input in decision-making processes, and act as a quality liaison for assigned projects.
Requirements:
- Strong knowledge/experience of PV/Quality/Regulatory Authority, including Quality Management for Pharmacovigilance.
- Qualification and experience as an auditor.
- Line management experience.
- Expert knowledge/experience in Pharmacovigilance Audits, Pharmacovigilance, and/or Quality Assurance.
- Degree in natural science or equivalent number of years' experience.
- Expert knowledge/experience in relevant regulations and guidance documents, such as Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs, and Pharmacovigilance.
Salary: £80,000 - £110,000 per annum, depending on experience, with up to 10% travel expected. We offer a hybrid UK-based role with our office in Marlow, Bucks. As an equal opportunities employer, we welcome applications from diverse candidates. If you require additional support during the interview process, please let us know in confidence.
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