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 Manager, R&D QA, Global Audit, Inspections and R&D Quality is responsible for managing Quality Assurance systems, processes and conducting internal and external audits and reviews, training, and reporting according to KK standards. The R&D 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 R&D 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. Involvement in clinical trials includes, but is not limited to, independent review and approval of deviations and CAPAs, GCP guidance, and quality agreement preparation.
• Develops and delivers GCP-related training to KK staff as needed.
• Performs, reports assigned GCP/GLP audits of KK studies, including but not limited to, clinical investigator sites, vendor/CROs, internal system/processes, clinical data and documents, as applicable.
• Prepares timely well-written reports, obtains/evaluates audit responses and oversees tracking mechanism for QA audits and manages CAPA as per KK standards.

Position Requirements

• Bachelor’s degree required and in science/life sciences preferred.
• Strong experience in drug development and 3+ years of experience in GCP/GLP Quality Assurance including detailed knowledge of EMA, FDA, MHRA, ICH regulations and other applicable regulatory requirements.

Kyowa Kirin International is an equal opportunities employer.

No agencies please.