QA Operations Projects & Strategy Expert (m/w/d)

With over 120 years of experience and around 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is committed to discovering, developing and providing new nursing standards that enrich the quality of life worldwide. In Europe, we focus on two areas: The aim of our specialty business is to protect people from cardiovascular diseases, the most common cause of death in Europe, and the patients suffering from it, to help enjoy every precious moment of life. In the field of Clinical Supply Planning & Operations, you play a central role in the global distribution of clinical trials. You ensure that IMPs, intermediate stages, finished products and laboratory samples reach their destinations efficiently, compliant and on time. You work closely with international partners in Japan, the USA and Europe. From now on we are looking for a dedicated/n for our location in Pfaffenhofen Senior Account Manager (m/w/d) Position: Daiichi Sankyo invests in state-of-the-art production units for aseptic filling and lyophilization of high-potent medicines. To strengthen our team, we are looking for a Project Manager – QA Operations with GMP experience in quality assurance in pharmaceutical production. Our location is in a strong growth phase. In addition to the existing production areas such as solida production, we develop new areas for the production of our ADC products. In your role, you work closely with the QA Operations areas and interdisciplinary teams in cross-site projects. In addition, you are responsible for QA Operations projects to unify and optimize our QA processes. With your work, you will significantly shape the QA Operations area.

Acquisition of (partial) projects in the QA Operations Area and other areas of expertise, e.g. when building new production areas taking into account the GMP requirements. Responsible planning, development and implementation of quality systems, SOP structures and processes within the new QA structures of Daiichi Sankyo Europe GmbH. Close cooperation with external service providers and internal departments on QA Operations topics. Participation in QA projects, e.g. qualification and validation activities and document reviews (SOPs, risk analyses). Support for cross-project QA events. Support for QM-relevant activities as required.

Complete university studies, pharmacists or comparable qualifications. At least 2 years of experience in quality management within a GMP-regulated environment. Ideally, additional experience in project management, preferably in the area of quality management. Very good knowledge of national and international legal regulations. Experience with inspections, including U.S. FDA, is desirable. Good knowledge of MS Office and SAP. Very good knowledge of German and English in word and writing. Embossed team and communication skills. Exact mode of operation, flexibility and enforcement. .