Senior Manager Api Quality Operations

Bristol Myers Squibb

Competitive salary; annual bonus included; pension...
Hybrid (50% onsite)
Api quality operations management
Cgmp regulations usa eu international
Contract manufacturer relationship management
Bristol Myers Squibb is seeking a Senior Manager of API Quality Operations to oversee quality and compliance in contract manufacturing organizations. The role emphasizes relationship management and quality assurance within the pharmaceutical industry, requiring a strong background in API manufacture and regulatory affairs

Job Summary

  • This role provides quality operations and compliance oversight for Active Pharmaceutical Ingredient and intermediate contract manufacturing organizations.
  • The position requires managing vendor approvals, quality events, change controls, and market complaints programs for external partners.
  • Employees will enjoy a competitive salary, annual bonus, pension contribution, family health insurance, and 27 days of annual leave.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Manager of API Quality Operations to oversee quality and compliance in contract manufacturing organizations. The role emphasizes relationship management and quality assurance within the pharmaceutical industry, requiring a strong background in API manufacture and regulatory affairs.

Salary

Competitive salary; Annual bonus included; Pension contribution, family health insurance, 27 days annual leave, gym access, life assurance

Skills & Requirements

Must-have

  • API quality operations management
  • cGMP regulations USA EU international
  • Contract manufacturer relationship management
  • Process validation protocol review
  • Quality agreement negotiation

Nice-to-have

  • Strong analytical problem solving skills
  • Experience with Technical Transfer projects
  • Virtual Plant Team leadership experience
  • Cross-functional team collaboration
  • Proactive direct report development

Key Requirements

  • Five years pharmaceutical industry experience in API manufacture
  • Extensive knowledge of chemical biological pharmaceutical operations
  • In-depth knowledge of cGMP regulations for USA EU and other markets
  • Ability to influence quality decisions at external manufacturers

Work Rights

Not specified

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