Team Lead (m­­/­­f­­/­­x) CMO Management QA

As Team Lead CMO Management QA you are responsible for leading a team of highly educated and experienced people, which act as primary contact for quality related topics to our Contract Manufacturing Organizations (CMOs). Furthermore, you act as primary contact for assigned overarching, management level related topics for both internal and external stakeholders in an international and very dynamic work environment from development until end of commercial life cycle. Your tasks include day-to-day business as well as strategic related topics and objectives and require communication with different functions and management levels. Roles and responsibilities: Manage a team for quality oversight for CMOs located in Europe : You are responsible as leader for a team of 4-5 people You work together with different functions from global QA, CMC, Regulatory Affairs and Supply Chain in a matrix organization to support your team to solve challenges in the day-to-day business related to CMO management You set strategies for optimal day-to-day business operations for your team and make sure the expectations from internal and external stakeholders are fulfilled You understand the needs of your team and you are able to develop people on a personal and professional level You are able to interact with management level at CMOs and in case necessary you take over quality-related, overarching topics connected to CMOs You are able to review and evaluate documents like APQRs, PPQ reports or CTDs if required You support the organization during Authority Inspections in your area of responsibility and perform audits on behalf of DS at different suppliers as needed You monitor quality-related information from different markets to ensure early recognition of trends related to your area of responsibility You provide such information to global teams and SMEs to identify quality-related risks at an early stage and support on every level to find suitable mitigation measures Participate in the further development of the corporate QM-System You act as a SME to help improving the global Daiichi-Sankyo QMS and global SOP landscape Share knowledge and expertise within the DS network to improve QA and CMO management at DS In this role you will work globally in close cooperation with other departments like Supply Chain, CMC, Regulatory Affairs and others to ensure consistent supply to markets with products which meet our high-quality standards at any time. This requires an extensive understanding of the pharmaceutical industry and multi-cultural work environments.