Manager, R&D QA, Global Audit, Inspections and R&D Quality

Manager, R&D QA, Global Audit, Inspections and R&D Quality

Kyowa Kirin International

Marlow, United Kingdom

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.

Responsibilities

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.

Qualifications

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.