About this role
About the Role In this role, you support the primary contact for quality-related topics (CMO-MQ) at Contract Manufacturing Organizations (CMOs). You will help manage quality oversight, implementing and maintaining Daiichi Sankyo quality standards (GMP/GDP) and regulatory requirements for our oncology products, and provide quality-related support to DS functions. What You'll Do
- Manage quality oversight at CMOs by acting as the responsible person for quality-related topics (change controls, deviations, and complaints) and independently processing assigned tasks.
- Track timely implementation of CAPAs related to deviations or audit findings and verify their effectiveness in collaboration with the CMO and internal stakeholders.
- Review, evaluate, and approve documents such as complaint investigations, deviation reports, and change controls, ensuring relevant stakeholders are involved when necessary.
- Ensure CMOs operate in compliance with established QAA and international GMP guidelines; support CMO-MQs during authority inspections as needed.
- Collect data from CMOs and process the data according to internal SOPs.
- Act as a global information distributor by supporting global teams and SMEs in identifying quality needs for CMOs and sharing quality-related information with global stakeholders in the QA environment and in cross-functional meetings.
- Participate in the ongoing development of the corporate Quality Management System and the global SOP landscape; collaborate with Supply Chain, Tech Management, Regulatory Affairs, and other functions to ensure consistent product supply. What We're Looking For
- Education: University degree (Bachelor) in natural or pharmaceutical sciences with at least 3 years of relevant experience, or vocational training with at least 6 years of relevant experience.
- Experience: 2–5 years of experience, including at least 3 years in Quality Assurance/Quality Management (QA/QM) and at least 1 year in QA oversight for manufacturing activities; at least 2 years in a GxP environment.
- Skills: Excellent knowledge of international GMP/GDP regulations; strong assertiveness and communication skills with a diplomatic negotiation style; true team player with a strong quality mindset and solution-oriented approach; very good written and verbal English and German.
- Additional: Experience in managing CMOs or external suppliers is beneficial; willingness to travel up to 10% (domestic and international). Nice to Have
- Experience in managing CMOs or external suppliers is beneficial. Compensation & Benefits
- Salary and benefits information is not disclosed in this posting.