Senior Manager Quality Assurance - Biologics (m/f/d)

Otsuka Novel Products GmbH (ONPG) is an affiliate of Otsuka Pharmaceutical Co., Ltd., a global healthcare company headquartered in Tokyo, Japan. The Group compromises a network of 168 subsidiaries and 34,400 employees in 32 countries across Europe, Asia-Pacific, the Americas, and the Middle East.

As part of Otsuka's Global Tuberculosis program, ONPG is dedicated to driving efforts to fight tuberculosis through innovative research and development, equitable access to medicines, and collaborations and capacity-building initiatives that strengthen the quality and delivery of care around the world. Rooted in the Otsuka philosophy – “Otsuka – people creating new products for better health worldwide” – we collaborate with a diverse range of organizations to pursue a shared vision, contributing focused expertise, innovation, and the resolve to end tuberculosis.

To strengthen our Quality team in Munich, we are currently recruiting for a

Senior Manager Quality Assurance - Biologics (m/f/d)
part-time (30 hours/week)

In this role, you will have quality oversight of the latest approved biological product at Otsuka, ensuring manufacturing, packaging, labelling, storage and transport is in accordance with regulatory expectations, applicable GMP/GDP standards for biologics and corporate requirements. You will bring Biologics Quality Assurance support, including oversight of upstream and downstream manufacturing processes, by collaborating with other Otsuka affiliates based in the US, Japan and relevant CMOs in Germany and the US.
You will be an integral part of the ONPG QMS, working closely with the releasing QP, and acting in the legal role of Deputy Head of Production.

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