At a Glance
- Tasks: Ensure quality oversight of clinical products and support regulatory submissions.
- Company: Kyowa Kirin International plc, 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 worldwide.
- Why this job: Play a crucial role in ensuring product quality and compliance globally.
- Qualifications: Experience in quality assurance and knowledge of GMP/GDP guidelines.
The predicted salary is between 70000 - 90000 £ per year.
Kyowa Kirin International plc is seeking an Associate Director Global CMC QA to provide end-to-end quality oversight of clinical IMPs in line with EU GMP/EudraLex Annex 13 and EU GDP guidelines. The role includes QP certification support, NGO oversight of CDMOs and 3PLs, and regulatory submissions through the product lifecycle.
The position focuses on ensuring traceability, data integrity, and compliance across manufacturing, packaging, testing, and distribution activities within a global context.
Global CMC QA Lead - Clinical GMP/GDP in Marlow employer: Kyowa Kirin International plc.
Kyowa Kirin International plc. is an exceptional employer located in the picturesque town of Marlow, offering a dynamic work environment where quality and compliance are at the forefront of our mission. Employees benefit from a collaborative culture that fosters professional growth and development, alongside competitive remuneration and benefits. Join us to be part of a dedicated team making a significant impact on global product quality in the pharmaceutical industry.
Contact Details:
Kyowa Kirin International plc. Recruitment Team
