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Senior Quality Manager CMO

vor 2 Monaten


Pfaffenhofen an der Ilm, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit
Job Title: Senior Quality Manager CMO

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 international GMP/GDP regulations.
  • 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 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.
  • Excellent knowledge of international GMP/GDP regulations.
  • Expertise in parenteral biological manufacturing, particularly in the manufacture of sterile medicinal products or biological active substances.

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 experts, contribute to the development of our corporate QM-System, and share your knowledge and expertise to improve CMO management at DS.