Manager, GCP/GLP QA

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 based in the UK, hybrid with our Marlow, Buckinghamshire office

Job Purpose:

You are responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The GCP/GLP QA Manager will support the QA program to assure the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The GCP/GLP QA Manager will collaborate and provide key quality input to KK’s R&D function.

Key Responsibilities:

• Acts as key point of contact for GCP/GLP quality issues reported by KK staff and provides ongoing feedback to management on potential quality-related risks
• Maintains high degree of knowledge of global industry expectations and GCP/GLP regulations to act as a key point of contact for KK staff, providing information and expert guidance on regulations and procedures
• Develops and delivers GCP-related training to KK staff as needed
• Supports process improvement initiatives, develops/administers SOPs
• Participates in Health Authority inspection activities for domestic and international projects (as applicable)
• Performs, reports assigned GCP/GLP audits of KK studies
• Provides input to the annual risk-based audit plan, schedule and execution of audits
• Prepares timely well-written reports, obtains/evaluates audit responses and oversees tracking mechanism for QA audits and manages CAPA

Position Requirements:

• Bachelor’s degree required in science/life sciences preferred
• Strong experience in drug development and strong experience in GCP/GLP Quality Assurance including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements
• Proficiency in MS Office Suite is essential
• Use of Veeva or similar QMS systems for electronic QA Management preferred
• Good working knowledge of international GxPs

Kyowa Kirin International is an equal opportunities employer

No agencies please.