Senior Manager, GVP Quality

at Kyowa Kirin International plc

Madrid, Spain or Marlow, UK

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

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.

To participate in the implementation, execution, delivery and maintenance of the EMEA GxP Quality Management Systems and be the subject matter expert in the KK QMS. Key areas of interest for this individual will be taking responsibility for Deviation, CAPA and Complaints Management and Self- Inspections performance.

This role can be based in UK or Spain

• Provide input into and maintain the Strategy Document
• Perform annual risk assessment
• Develop, maintain and provide input to an adequate audit plan for global, regional and local trials, systems and compliance processes
• Manage qualified service providers for GQA, e.g., contract auditors
• Manage audits and contract auditors in line with the audit plan, Kyowa Kirin’s business model and applicable procedures
• Develop, and mentor junior PV audit team
• Ensure that a comprehensive PV Quality System is developed, in place and adhered to
• Ensure continuous improvement and enhancement of the PV Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’
• Collaborate with the respective Functional Area Heads
• Collaborate with the respective Global and Regional Quality Leads and functions
• 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
• Manage deviations reported by the Functional Areas and support them with resolution
• Support inspections and health authority inspection management
• Support the preparation for GVP inspections
• Support the responses to Regulatory Authorities
• Support and provide input to the corrective and preventive actions

• Degree in natural science or equivalent number of years’ experience
• Qualified auditor; Experience of Quality Management Auditing for Pharmacovigilance
• Clinical/industry/Regulatory Authority or otherwise relevant experience,
• Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, and Regulatory Affairs