Senior Quality Manager CMO (m­­/­­f­­/­­x) - Drug Product Manufacturing

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 and 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 You are responsible for quality related topics like change control, deviations and/or complaints related to 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 The QM CMO is the person responsible for preparing and negotiating QAAs with CMOs and ensures the CMOs work in accordance with DS QAAs You are involved in establishment of new manufacturing processes and site transfer activities and act as quality subject matter expert supporting PPQ and validation activities You support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed In this role you identify quality risks at our CMOs and escalate issues in case it becomes necessary Act as global information distributor 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 Participate in the further development of the corporate QM-System In global working teams you act as SME to improve the DS quality system and global SOP landscape 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.