Director of Global Pharmacovigilance Quality Assurance

2 weeks ago


Marlow, United Kingdom Kyowa Kirin Full time
Job Title: Director GVP Quality

At Kyowa Kirin International, we are committed to making a difference in the lives of those who need it most. As a Director of Global Pharmacovigilance Quality Assurance, you will play a critical role in ensuring the quality and integrity of our pharmacovigilance processes.

Key Responsibilities:
  • Develop and execute the Global Pharmacovigilance Audit Strategy and Schedule in collaboration with the Global Head of GxP Inspections & GVP Quality.
  • Maintain risk standards and methodologies, audit methodology, and best practices to ensure consistency of approach.
  • Support the continuous improvement of Kyowa Kirin's Quality System, including PV inspections, regulatory intelligence activities, SOP and WI management, and project liaison activities.
  • Lead the annual risk assessment and manage the audit plan for global and regional GVP entities.
  • Conduct and manage audits, including contract auditors, in line with the audit plan, Kyowa Kirin's business model, and applicable procedures.
Requirements:
  • Strong knowledge and experience of PV/Quality/Regulatory Authority, including Quality Management for Pharmacovigilance.
  • Qualification and experience as an auditor.
  • Line management experience.
  • Expert knowledge and experience in Pharmacovigilance Audits, Pharmacovigilance, and/or Quality Assurance.
  • Degree in natural science or equivalent number of years' experience.
What We Offer:

As a Director of Global Pharmacovigilance Quality Assurance at Kyowa Kirin International, you will have the opportunity to work with a talented team of professionals who are passionate about making a difference in the lives of others. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

We are an equal opportunities employer and welcome applications from diverse candidates. If you require any additional support through the interview process, please do not hesitate to contact us.



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