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Senior Quality Manager CMO

vor 2 Monaten


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

About the Role:

We are seeking a highly qualified Senior Quality Manager CMO to join our team at Daiichi Sankyo Europe GmbH. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality of our products manufactured by Contract Manufacturing Organizations (CMOs).

Key Responsibilities:

  • Manage quality oversight at CMOs, ensuring compliance with regulatory requirements and Daiichi Sankyo's quality standards.
  • Develop and implement effective CAPAs and track their 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 Daiichi Sankyo's QAAs.
  • Support CMOs during Authority Inspections and perform audits on behalf of Daiichi Sankyo at different suppliers.
  • Identify quality risks at CMOs and escalate issues as necessary.

What You'll Bring:

  • Proven experience in quality assurance, preferably in a pharmaceutical or biotechnology industry.
  • Strong knowledge of regulatory requirements and industry standards.
  • Excellent communication and negotiation skills.
  • Ability to work independently and as part of a global team.

Why Daiichi Sankyo?

We are a global pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that enrich the quality of life for patients around the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada. We foster a culture of mutual respect, continuous learning, and inclusion, and we are committed to making a positive impact on society.