Manager GxP Inspections

Manager, Global GxP Inspections

at Kyowa Kirin International plc

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.

This role is hybrid with our offices in UK (Marlow, Buckinghamshire), The Netherlands (Hoofddorp) or Spain (Madrid)

Job Purpose:

To provide Global Kyowa Kirin organisations with GxP inspection support pre, during and post regulatory inspections at company sites as necessary. You will provide support to all global operations.

Key Responsibilities:

• Support inspections and health authority inspections management, collaborate effectively with colleagues across all sites to support inspection readiness as required
• Maintain full awareness of global GxP requirements for global inspectorates
• Support the GxP functions, sites and the QA Leads by providing project-managed audit/s
• Support the development, implementation, continuous improvement, and documentation of Kyowa Kirin’s quality system
• Identify process gaps and deficiencies in the quality system and work to find a resolution
• Ensure SOPs/ WIs are compliant with applicable requirements and regulations
• Provide sound advice and interpretations related to current GxP guidelines and regulations to Senior Management and Kyowa Kirin’s employees

Position Requirements:

• Degree in natural science or equivalent strong experience
• Inspection management or project management
• Inspection readiness activities
• Excellent working knowledge of CAPA and RCA
• Broad experience of working within the pharmaceutical and/or biotechnology industry with experience of operating in a QA Management position
• Good working knowledge of international GxPs, especially in the interpretation of UK MHRA, EMA and US FDA and PMDA requirements, for the manufacture, control and distribution of commercial product, clinical trial supplies and pharmacovigilance

Kyowa Kirin International is an equal opportunities employer

No agencies please.