Senior Quality Manager CMO

vor 4 Wochen

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

At Daiichi Sankyo Europe, we are seeking a highly qualified Senior Quality Manager CMO to join our team. This role will be responsible for managing quality oversight at Contract Manufacturing Organizations (CMOs) and ensuring that our products meet the highest quality standards.

Key Responsibilities:
  • Manage quality oversight at CMOs, including change control, deviations, and complaints related to DS products.
  • Define effective CAPAs and track timely implementation with CMOs.
  • 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/FH/Master 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.

We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced quality professional, we encourage you to apply for this exciting opportunity.

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