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

We are looking for a Manager, R&D QA, Global Audit, Inspections and R&D Quality to manage Quality Assurance systems, processes and conduct internal and external audits and reviews, training, and reporting according to KK standards. The role 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.

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