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
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Global CMC QA Lead - Clinical GMP/GDP in Marlow employer: Kyowa Kirin International
At Kyowa Kirin International, we pride ourselves on fostering a culture of teamwork, innovation, and integrity, making it an exceptional place for IT Security Engineers to thrive. Located in Marlow, our inclusive environment not only prioritises employee well-being but also offers ample opportunities for professional growth and development within the pharmaceutical sector. Join us to be part of a dedicated team that is committed to making a meaningful impact on patients' lives while advancing your career in a supportive and dynamic setting.