Manager, Quality Operations

Bristol Myers Squibb

50% onsite
Contract manufacturing organization (cmo) management
Cgmp and international regulatory standards
Product disposition and batch documentation
Bristol Myers Squibb is seeking a Manager of Quality Operations to oversee quality compliance and documentation with Contract Manufacturing Organizations (CMOs). The role requires expertise in pharmaceutical operations and quality assurance, specifically with biologics and sterile manufacturing

Job Summary

  • This role provides quality oversight of Contract Manufacturing Organizations to ensure compliance with Bristol Myers Squibb and global regulatory standards for biologics.
  • The position requires authoring and reviewing disposition documentation, managing Annual Product Quality Reviews, and supporting inspection readiness for new products.
  • Bristol Myers Squibb offers a flexible work environment with competitive benefits designed to support employees' professional growth and personal lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Manager of Quality Operations to oversee quality compliance and documentation with Contract Manufacturing Organizations (CMOs). The role requires expertise in pharmaceutical operations and quality assurance, specifically with biologics and sterile manufacturing.

Skills & Requirements

Must-have

  • Contract Manufacturing Organization (CMO) management
  • cGMP and international regulatory standards
  • Product disposition and batch documentation
  • Annual Product Quality Review (APQR)
  • Deviation and CAPA resolution expertise
  • SAP and Quality Management System proficiency

Nice-to-have

  • Strong negotiation and influencing skills
  • German language knowledge
  • Experience with combination products
  • Strategic thinking in ambiguous environments
  • Technical writing for investigations and protocols

Key Requirements

  • Minimum B.S. degree in Biochemistry, Microbiology, Pharmacy, or related field
  • Minimum 4 years experience in pharmaceutical operations at manufacturing site
  • At least 2 years in Quality, ideally in product release or pharma project quality
  • Experience in aseptic, sterile, and biological drug product manufacturing
  • Experience with contract manufacturing or contract testing

Work Rights

Not specified

Tailored Resume

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