Quality Assurance Manager

vor 17 Stunden

Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit
About Daiichi Sankyo Europe

We are a global pharmaceutical company dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. With over 120 years of experience and more than 17,000 employees in over 20 countries, we strive to protect people from cardiovascular disease, the leading cause of death in Europe.

Job Description: Senior Quality Manager CMO

We are seeking a highly qualified candidate to fill the position of Senior Quality Manager for Contract Manufacturers (CMOs) in our European headquarters in Munich, Germany. As a key member of our team, you will be responsible for managing quality oversight at CMOs, ensuring compliance with international GMP/GDP regulations, and driving continuous improvement in our quality management system.

The ideal candidate will have a university 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, are required. Excellent knowledge of international GMP/GDP regulations and expertise in parenteral biological manufacturing are highly desirable.

Responsibilities:
  • Manage quality oversight at CMOs, including change control, deviations, and complaints related to DS products.
  • Develop effective CAPAs and track timely implementation.
  • Review, evaluate, and approve documents such as APQRs, PPQ reports, or CPVs.
  • Negotiate QAAs with CMOs and ensure their compliance with DS QAAs.
  • Support CMOs during Authority Inspections and perform audits on behalf of DS as needed.
Requirements:
  • University/FH/Master degree in natural or pharmaceutical sciences.
  • At least five years of relevant work experience in the pharmaceutical industry.
  • Excellent knowledge of international GMP/GDP regulations.
  • Expertise in parenteral biological manufacturing is desired.
What We Offer:

A competitive salary between €80,000 and €110,000 per annum, depending on qualifications and experience, plus additional benefits and opportunities for professional growth and development.

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