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Senior Quality Manager (m/f/d) CMO - Monoclonal Antibody Manufacturing
Senior Quality Manager (m/f/d) CMO - Monoclonal Antibody Manufacturing
Daiichi Sankyo Europe GmbH
Pfaffenhofen an der Ilm
In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs. Your responsibilities include implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements at external contract manufacturers for our oncology products. Furthermore, you support other DS functions as an expert in quality topics and processes. * Manage quality oversight at CMOs - o You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs - o You are involved in establishment of new manufacturing processes and site transfer activities and act as quality supporting PPQ and validation activities - o In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary
In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs). As QM CMO you manage the quality oversight at the CMOs. Your responsibilities include implementation and maintaining of DS quality standards (GMP/GDP) and regulatory requirements at external contract manufacturers for our oncology products. Furthermore, you support other DS functions as an expert in quality topics and processes. * Manage quality oversight at CMOs - o You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs - o You are involved in establishment of new manufacturing processes and site transfer activities and act as quality supporting PPQ and validation activities - o In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary
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