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At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

Responsibilities

Development and execution of the Global Pharmacovigilance (GVP) Audit Strategy and Global Pharmacovigilance Audit Schedule in close collaboration with the Global Head of GxP Inspections & GVP Quality. This includes maintaining risk standards and methodologies, audit methodology and best practices to ensure consistency of approach. Additional tasks are to support the continuous improvement of the Kyowa Kirin’s Quality System, support PV inspections, support regulatory intelligence activities, SOP and WI management, and project liaison activities.

Please note this a hybrid UK based role, with our office in Marlow, Bucks. There will be some travel expected - up to 10%

Key Responsibilities: Line management for 5 staff, in addition to:

• GVP Audits:
• Plan, conduct, and support internal and external GVP audits
• Follow-up on the development, implementation, and completion of corrective and preventive actions with internal and external auditees
• Maintain adequate oversight of audits, findings and corrective and preventive actions in eQMS
• Contribute to the improvement and enhancement of the auditing process
• Delegation of Global Head responsibilities as assigned, e.g., audit report signatory.
• Lead the annual risk assessment
• Manage the audit plan for global & regional GVP entities for affiliates, partners vendors and processes
• Select and manage qualified service providers for GQA, e.g., contract auditors
• Conduct and manage audits, including contract auditors in line with the audit plan, Kyowa Kirin’s business model and applicable procedures

Quality Management System:

• Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned’ from audit/inspection
• Lead collaboration with the respective Functional Area Heads
• Lead collaboration with the respective Global and Regional Quality Leads
• Foster a continuous improvement mentality within Kyowa Kirin
• Ensure the establishment and maintenance of the required Quality Documentation
• Identify process gaps and deficiencies in the Quality System, liaise and collaborate continuously with other Functional Areas and other partners for resolution

Support inspections and health authority inspection management:

• Lead the support conduct of GVP/GCP inspections
• Lead the QC of responses to Regulatory Authorities
• Supervise and provide input to the corrective and preventive actions
• Follow-up on the development, implementation, and completion of corrective and preventive actions with the inspected Functional Areas
• Maintain oversight and awareness of GVP inspections, findings, and corrective and preventive actions

Provide advice and act as project liaison:

• Provide sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and Kyowa Kirin’s employees
• Be accountable for quality-related input in decision making processes with relevance for GxP compliance
• Act as quality liaison for assigned projects

Qualifications

Position Requirements:

• Very 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, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance

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