Senior Quality Manager CMO

vor 2 Monaten

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

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 global quality assurance team, you will be responsible for ensuring the quality of our products manufactured by contract manufacturers (CMOs).

Key Responsibilities

  • Manage quality oversight at CMOs, including change control, deviations, and complaints related to manufacturing of Daiichi Sankyo products.
  • Define and implement effective corrective and preventive actions (CAPAs) with CMOs to ensure timely implementation.
  • Review, evaluate, and approve documents such as audit reports, process validation reports, and change control records.
  • Negotiate and manage quality agreements with CMOs to ensure compliance with Daiichi Sankyo's quality standards.
  • 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.

Requirements

  • Proven experience in quality assurance and regulatory compliance in the pharmaceutical industry.
  • Strong knowledge of GMP regulations and industry standards.
  • Excellent communication and negotiation skills.
  • Ability to work independently and as part of a global team.

What We Offer

Daiichi Sankyo Europe offers a dynamic and challenging work environment, with opportunities for professional growth and development. We foster a culture of mutual respect, continuous learning, and inclusion and diversity. If you have a passion for quality and a proactive mindset, we encourage you to apply for this exciting opportunity.

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