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.

Job Purpose

The Global Head of GCP/GLP Audits and R&D Quality Assurance is responsible for the development and execution of the Global GCP/GLP Audit Strategy and GCP/GLP Audit Plan, and providing GCP QA expertise to R&D stakeholders. This includes managing the Global GCP/GLP Quality Assurance team and setting audit standards and best practices to ensure consistency of audit conduct and risks/gap identification across all regions.

Additional tasks include continued improvement of the Quality Assurance system, processes, provision of GCP guidance, training and deviation/CAPA approval to R&D business partners, as well as participation in regulatory intelligence activities.

Ensures that the GCP/GLP audit program allows insurance of the accuracy and quality of scientific data submitted to regulatory agencies in support of new drug applications and/or biological licensing agreement applications. The position requires close collaboration and partnership with KK’s R&D functions.

Maintains a high degree of knowledge of global industry expectations, GCP/GLP regulations and provides expert advice/guidance to KK staff in support of clinical trials.

Key Responsibilities:

Audit process

• Responsible for strategy and leads the development of the annual global GCP/GLP audit plan, based on a risk-assessment of R&D and Medical Affairs vendors, clinical trial protocols and processes.
• Oversees the GCP/GLP audit team leads and their team members to ensure timely & well-written audit reports & CAPA completion.
• Ensures continuous improvement and enhancement of the GCP/GLP Quality System by leading global metrics generation and ‘lessons learned from audit/
• Mentors and trains junior team managers and auditors, reviews and provides feedback to management on the progress and provides individualised training initiatives as necessary.
• Oversight and strategy of Standard Operating Procedures (SOPs) and Working Instructions (WIs).

Clinical Trial Support

• Drives the harmonisation of the structures built to deliver GCP/GLP QA expertise to the business, to ensure consistency across regions and that resources are used efficiently.
• Ensures the team provides adequate GCP and GLP/Standard of Reliability guidance related to current GCP/GLP guidelines and regulations to clinical trial teams on assigned clinical trials
• Collaborates with the respective R&D Functional Heads & respective Global and Regional Quality Leads and Clinical Quality Compliance heads.
• Is accountable for quality input into decision-making processes ensuring GCP/GLP compliance.
• Oversight and strategy of Standard Operating Procedures (SOPs) and Working Instructions (WIs)

Support health authority inspection management in collaboration with Global Head of GxP Inspections

• Leads & coordinates GCP Health Authority inspection activities for domestic and international projects (as applicable).
• Supports GCP inspection readiness training to R&D functions/arranges mock inspections.
• Ensures the GCP/GLP/R&D QA team supports the development, implementation, and completion of corrective and preventive actions with the inspected clinical trial teams.

Position Requirements

• Bachelor’s Degree in science/life sciences preferred with strong experience in drug development and experience in GCP/GLP operations/auditing including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements.
• Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Clinical Development, Non-Clinical Development, Medical Device, or IMP management.
• Excellent leadership skills and knowledge of working in a cross-cultural business environment
• Analytical and creative thinking / Problem solving and resolution skills
• Effective technical verbal and writing communication and presentation skills as well as strong interpersonal skills and experience communicating to multinational audience, including in communicating difficult messages to senior management and influencing behaviours that will result in increased GCP/GLP compliance.
• Well versed with MS Office
• Attention to detail and accuracy while being flexible, ability to adapt to changing priorities.
• Ability to travel internationally as needed.

Kyowa Kirin International is an equal opportunities employer.

No agencies please.