Global CMC QA Lead - Clinical GMP / GDP
Kyowa Kirin International, Marlow, Buckinghamshire
Global CMC QA Lead - Clinical GMP / GDP
Salary not available. View on company website.
Kyowa Kirin International, Marlow, Buckinghamshire
- Full time
- Permanent
- Onsite working
Posted 2 days ago, 27 Aug | Get your application in today.
Closing date: Closing date not specified
Job ref: 8884997069b0479fbf87aea763166467
Location ref: Marlow, Buckinghamshire
Full Job Description
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, 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