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 QU 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
- 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 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
