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European Quality Assurance Director
vor 1 Monat
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: cardiovascular disease and oncology. We strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
About the RoleWe are seeking a highly qualified Senior Quality Manager CMO (m/f/x) – Drug Product Manufacturing to join our team. This is an excellent opportunity for you to work globally in close cooperation with other departments like Supply Chain, CMC, regulatory functions and others to ensure consistent supply to markets with products which meet our high quality standards at any time.
Main Responsibilities- Manage quality oversight at Contract Manufacturing Organizations (CMOs) and define together with the CMO effective CAPAs and track the timely implementation
- Independently review, evaluate and approve documents like APQRs, PPQ reports or CPVs as DS QA
- Negotiate QAAs with CMOs and ensure they work in accordance with DS QAAs
- Act as quality subject matter expert supporting PPQ and validation activities
- Support CMOs during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
- University/FH/Master degree in natural or pharmaceutical sciences - preferred 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 – preferable 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
The ideal candidate will have excellent knowledge of international GMP/GDP regulations and expertise in parenteral biological manufacturing particularly in the manufacture of sterile medicinal products or of biological active substances is desired. The estimated salary for this position is approximately €80,000 per annum, depending on qualifications and experience.
