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 and escalate issues in case it becomes necessary Act as global information distributor within QA and to other departments In your new role you support global teams and SMEs to identify and define quality needs for CMOs You share quality related information from the CMOs to our global stakeholders within the global QA environment as well as in department overarching meetings You provide information from global stakeholders to the CMO and ensure timely implementation of agreed requirements Act as support for global and regional QA functions In global working teams you act as SME to improve the DS quality system and global SOP landscape Support regional QA functions for regulatory requests regarding e.g. GMP clearance or import license Share knowledge and expertise within QA or to other functions to improvement CMO management at DS In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, regulatory functions and others to ensure consistent supply to markets with products which meet our high quality standards at any time.