At a Glance
- Tasks: Ensure quality oversight of clinical products and compliance with EU regulations.
- 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 globally.
- Why this job: Play a crucial role in ensuring the safety and quality of innovative therapies.
- Qualifications: Experience in quality assurance and knowledge of GMP/GDP guidelines.
The predicted salary is between 72000 - 88000 £ 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, offering a dynamic work environment that prioritises quality and compliance in the pharmaceutical industry. With a strong commitment to employee development, we provide ample opportunities for growth and advancement, alongside a collaborative culture that values innovation and integrity. Located in a vibrant area, our team enjoys a supportive atmosphere that fosters both professional and personal fulfilment.
Contact Details:
Kyowa Kirin International plc. Recruitment Team
