Regulatory Affairs & Compliance Manager, Pet Production Facility

Mass General Brigham

Boston, Massachusetts, US
Base: $99,465.60 - $141,804.00/annual; bonus/equit...
Fully remote
Cgmp document authoring and review
Fda regulations and guidance library
Oos investigation coordination
Mass General Brigham relies on a wide range of professionals to advance its mission of patient care, research, teaching, and community service

Job Summary

  • Mass General Brigham relies on a wide range of professionals to advance its mission of patient care, research, teaching, and community service.
  • Duties include authoring and reviewing cGMP documents, managing investigations, change control, CAPA, and vendor complaints, and assisting with IND submissions.
  • The role involves maintaining an updated library of FDA regulations, ensuring inspectional readiness, and collaborating with PET Production/Cyclotron staff.

Matching Summary

Mass General Brigham relies on a wide range of professionals to advance its mission of patient care, research, teaching, and community service.

Salary

Base: $99,465.60 - $141,804.00/Annual; Bonus/Equity: Not specified; Benefits: Comprehensive benefits package offered

Skills & Requirements

Must-have

  • cGMP document authoring and review
  • FDA regulations and guidance library
  • OOS investigation coordination
  • Change control management
  • CAPA management and verification
  • Vendor complaint handling
  • IND submissions and reporting

Nice-to-have

  • Quality improvement culture development
  • Positive working relationships
  • Collaboration with industry partners

Key Requirements

  • Bachelor's degree required
  • 3-5 years pharmaceutical manufacturing experience
  • 2-3 years supervisory experience
  • Preferred: Certification in quality management or cGMP

Work Rights

Not specified

Tailored Resume

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