Pharmaceutical Quality Assurance Manager

vor 1 Tag

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

The Daiichi Sankyo Europe GmbH is seeking an experienced Pharmaceutical Quality Assurance Manager to join our team in Munich, Germany. This role requires a minimum of 8+ years of relevant work experience in the pharmaceutical industry, with at least 4+ years in Quality Assurance and/or Quality Management.

Job Description:

This position involves leading a team of quality professionals responsible for ensuring compliance with international GMP/GDP regulations. The successful candidate will have excellent knowledge of CMC regulatory and development, as well as experience in managing relationships with Contract Manufacturing Organizations (CMOs) or external supplier organizations.

Responsibilities:
  • Manage a team of quality professionals to ensure compliance with GMP/GDP regulations
  • Develop and implement quality management strategies to optimize day-to-day business operations
  • Review and evaluate documents such as APQRs, PPQ reports, and CTDs as required
  • Support the organization during Authority Inspections and perform audits on behalf of DS at different suppliers as needed
Requirements:
  • University degree in natural or pharmaceutical sciences, preferred in Pharmacy, Biotechnology, Biology, Chemistry, or a comparable program
  • At least 8+ years of relevant work experience in the pharmaceutical industry, including at least 4+ years in Quality Assurance and/or Quality Management
  • Excellent knowledge of international GMP/GDP regulations
  • Experience in managing relationships with CMOs or external supplier organizations
  • Proven track record of Project management and Leadership skills in Matrix Organizations is beneficial

Estimated salary: €90,000 - €110,000 per year.

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