At a Glance
- Tasks: Ensure quality oversight of clinical products and maintain compliance with EU regulations.
- Company: Kyowa Kirin International, a leader in biopharmaceuticals.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to improving patient outcomes globally.
- Why this job: Play a crucial role in ensuring the safety and efficacy of clinical products.
- Qualifications: Experience in QA within GMP/GDP environments and strong regulatory knowledge.
The predicted salary is between 60000 - 80000 £ per year.
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.
Global CMC QA Leader — Clinical GMP/GDP in Marlow employer: Kyowa Kirin International
Kyowa Kirin International is an exceptional employer, dedicated to embedding care into every aspect of our work, making a meaningful difference for patients and their families. Our inclusive culture, rooted in values such as Teamwork, Commitment to Life, Innovation, and Integrity, fosters an environment where employees are encouraged to take bold actions and drive life-changing solutions. With ample opportunities for professional growth and a commitment to continuous improvement, working at our Orchard location offers a unique chance to be part of a team that truly impacts lives.
