Global CMC QA Leader - Clinical GMP/GDP

Kyowa Kirin International is seeking an Associate Director Global CMC QU - Clinical GMP/GDP. The role provides end-to-end QA oversight of clinical IMPs in line with EU GMP Annex 13 and EU GDP guidelines, supporting QP certification and batch release, and overseeing CDMOs and 3PLs to ensure traceability and regulatory compliance.

You will review GMP documentation, lead audits, and contribute to regulatory submissions and health authority interactions while maintaining data integrity and quality