Senior Quality Manager CMO (m/f/x)

In your new role you act as the primary contact for all quality related topics at contract manufacturing organizations (CMOs) involved in the manufacturing of small molecules. You manage the quality oversight at the assigned CMOs, which include implementation and maintaining of Daiichi-Sankyo quality standards (GMP/GDP) as described per quality agreements and international regulatory requirements. Furthermore, you support other DS functions as an expert in quality related topics and processes and support the global organization in product oversight. Manage quality oversight at CMOs You are responsible for quality related topics like change control, deviations and/or complaints related to manufacturing of DS products at CMOs Define together with the CMO effective CAPAs and track the timely implementation As DS QA you independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs You are responsible for preparing and negotiating QAAs with CMOs and ensure the CMOs work in accordance with DS QAAs You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers In this role you additionally identify quality risks at our CMOs

---