Senior Quality Manager CMO
Vor 6 Tagen
About Daiichi Sankyo Europe
Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.
Job Summary
We are seeking a highly qualified Senior Quality Manager CMO to join our team in Munich, Germany. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our drug products manufactured by Contract Manufacturing Organizations (CMOs).
Key Responsibilities
- Manage quality oversight at CMOs, ensuring compliance with regulatory requirements and company standards.
- Develop and implement effective CAPAs and track timely implementation.
- Review, evaluate, and approve documents such as APQRs, PPQ reports, and CPVs.
- Negotiate QAAs with CMOs and ensure they work in accordance with DS QAAs.
- Support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed.
- Identify quality risks at our CMOs and escalate issues as necessary.
Requirements
- University/FH/Master degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a comparable program.
- At least five years of relevant work experience in the pharmaceutical industry, including:
- At least two years in Quality Assurance and/or Quality Management, preferably in Shop Floor QA activities or as QA Oversight for Manufacturing Activities for Sterile Manufacturing.
- At least two years in a GxP environment in a Fill&Finish manufacturing department for sterile solutions and/or lyophilisates.
- Excellent knowledge of international GMP/GDP regulations.
- Expertise in parenteral biological manufacturing, particularly in the manufacture of sterile medicinal products or of biological active substances, is desired.
What We Offer
As a Senior Quality Manager CMO at Daiichi Sankyo Europe, you will have the opportunity to work with a global team of professionals, contribute to the development of our corporate QM-System, and share your expertise with other functions to improve CMO management.
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