Regulatory Affairs & Compliance Manager, Pet Production Facility

Mass. Eye And Ear

Boston, Massachusetts, USA
Base: $99,465.60 - $141,804.00/annual; bonus/equit...
Fully remote
Cgmp document authoring and review
Fda regulations and guidance library
Annual product quality review
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.
  • The MGH PET Production Facility is an FDA registered PET Radiopharmaceutical manufacturing facility requiring expertise in cGMP.
  • The organization offers competitive base pay, comprehensive benefits, career advancement opportunities, and recognition programs.

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
  • Annual product quality review
  • OOS investigation coordination
  • Change control management
  • CAPA management and verification

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: cGMP certification

Work Rights

Not specified

Tailored Resume

Cover Letter