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.
Purpose of the function
In your new role, you support the primary contact for quality-related topics (CMO-MQ) at Contract Manufacturing Organizations (CMOs). You support the management of quality oversight at the CMOs, which includes the implementation and maintenance of DS quality standards (GMP/GDP) and regulatory requirements for our oncology products. Furthermore, you support other DS functions with quality-related topics and processes.
Roles and Responsibilities
- Manage quality oversight at CMOs
- You support the responsible person for quality-related topics, such as change controls, deviations, and/or complaints related to DS products at CMOs, and independently process assigned tasks.
- You track the timely implementation of CAPAs related to deviations or audit findings and verify their effectiveness in collaboration with the CMO and internal stakeholders.
- You review, evaluate, and approve documents such as complaint investigations, deviation reports, and change controls, ensuring that relevant stakeholders are involved whenever necessary.
- You ensure that the CMO operates in compliance with the established QAA and international GMP guidelines.
- You support CMO-MQs during authority inspections at different suppliers, as needed.
- You collect data from CMOs and process the data as described in internal SOPs.
- Act as a global information distributor
- In your new role, you support global teams and SMEs in identifying and defining quality needs for CMOs.
- You share quality-related information from the CMOs with our global stakeholders within the global QA environment, as well as in cross-functional meetings whenever necessary.
- Participate in the further development of the corporate Quality Management System
- You support global working teams in improving the DS Quality Management System and the global SOP landscape.
- In this role, you will work globally in close cooperation with other departments, including Supply Chain, Tech Management, Regulatory Affairs, and other functions, to ensure a consistent supply of products that meet our high quality standards at all times.
Education & Experience
Education:
- University degree (Bachelor's degree) in natural or pharmaceutical sciences with at least 3 years of relevant professional experience, or
- Vocational training in the pharmaceutical industry with at least 6 years of relevant professional experience.
Experience:
- 2–5 years of experience.
- At least 3 years of relevant work experience in the pharmaceutical industry, including:
- At least 1 year in Quality Assurance and/or Quality Management, preferably in Shop Floor QA activities or as QA Oversight for Manufacturing Activities.
- At least 2 years in a GxP environment in a position involved in manufacturing or comparable activities.
Skills and additional Requirements
- Excellent knowledge of international GMP/GDP regulations.
- Strong assertiveness and communication skills, combined with a diplomatic approach during negotiations.
- A true team player with a strong quality mindset and a solution-oriented approach.
- Very good written and verbal communication skills in English and German.
- Experience in managing CMOs or external suppliers is beneficial.
- Willingness to travel (up to 10%, domestic and international).
