PWith over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world./p pIn Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life./p pIn Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones./p pOur European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada./p pFor our site in Pfaffenhofen/Ilm we are seeking qualified candidates to fill the position:/p pb(Senior) Quality Manager (m/f/x) CMO/b/p pbrbPurpose of the function:/b/p pIn 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 CMO/manufacturing site, 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./pbrul liManage quality oversight at CMO/manufacturing site, including/li ul liHandling of quality related topics like change control, deviations and/or complaints related to manufacturing of DS products at CMOs/li liDefinition of effective CAPAs together with the CMO and tracking of the timely implementation/li liReview, evaluation and approval of documents like APQRs, Q reports or CPVs/li liPreparation and negotiation of QAAs with CMOs and ensure that the CMOs work in accordance with DS QAAs/li liSupport CMOs during Authority Inspections and audits on behalf of DS at different suppliers/li liIdentification of quality risks at our CMOs and escalation of issues in case it becomes necessary/li /ul liAct as information distributor within QA and to other departments/li ul liIn your new role you support local and global teams and SMEs to identify and define quality needs for CMOs/li liYou share quality related information from the CMOs to our regional and global stakeholders within the QA environment as well as in department overarching meetings/li