Quality Manager CMO (m/w/d) - Small Molecules - 24 Months Contract

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. Position Location: Munich, Germany Roles and Responsibilities Quality Oversight at CMO/Manufacturing Site Handle quality-related topics such as change control, deviations, and/or complaints related to the manufacturing of DS products at CMOs Define effective CAPAs together with the CMO and track timely implementation Review, evaluate, and approve documents such as APQRs, PPQ reports, and CPVs Prepare and negotiate QAAs with CMOs and ensure that CMOs work in accordance with DS QAAs Support CMOs during authority inspections and audits on behalf of DS at different suppliers Identify quality risks at CMOs and elevate issues where necessary Information Distribution Within QA And Other Departments Support local and global teams and SMEs to identify and define quality needs for CMOs Share quality-related information from CMOs with regional and global stakeholders within the QA environment as well as in cross-departmental meetings Distribute information from stakeholders to the CMO and ensure timely implementation of agreed requirements Support For Global And Regional QA Functions Act as SME in global working teams to improve the DS quality system and global SOP landscape Support regional QA functions for regulatory requests regarding e.g. GMP clearance or import licence Share knowledge and expertise within QA and other functions to improve CMO management at DS In this role, you will work regionally and globally in close cooperation with other departments such as Supply Chain, CMC, and regulatory functions to ensure consistent supply to markets with products that meet our high quality standards at all times. Personal Skills and Professional Experience Education University/FH/Master's degree in natural or pharmaceutical sciences Experience 2–5 years of experience in the pharmaceutical industry 2–4 years of experience specifically in Quality Assurance (QA), Quality Management Systems (QMS), and a GMP-regulated environment Experience with managing CMOs or external suppliers is beneficial Competencies Excellent knowledge of international GMP/GDP regulations Expertise in small molecule manufacturing for Drug Substance and Drug Product Assertiveness and strong communication skills paired with a diplomatic attitude during negotiations Team player with high quality consciousness and a solution-oriented mindset Very good written and verbal communication skills in English and German Project management skills are desirable Willingness to travel (up to 10%, domestic and international) Why Work with Us? Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application. #J-18808-Ljbffr