Manager, Qa Compliance

RayzeBio

Indianapolis, IN, US
Base: $124,449 - $150,803; bonus/equity: + incenti...
Fully remote
Bachelor's degree in engineering or life science
5 years of quality assurance experience
Knowledge of us, eu, and global cgmp regulations
The role involves managing Site Quality Operations activities in accordance with RayzeBio policies and global cGMPs while leading the Change Control Review Board

Job Summary

  • The role involves managing Site Quality Operations activities in accordance with RayzeBio policies and global cGMPs while leading the Change Control Review Board.
  • Candidates will be responsible for developing quality metrics, leading the site Data Integrity Program, and participating in corporate or health authority inspections.
  • RayzeBio offers a competitive compensation range of $124,449 - $150,803 along with comprehensive benefits including medical, dental, vision, and flexible time off.

Matching Summary

The role involves managing Site Quality Operations activities in accordance with RayzeBio policies and global cGMPs while leading the Change Control Review Board.

Salary

Base: $124,449 - $150,803; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellbeing support

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or life science
  • 5 years of Quality Assurance experience
  • Knowledge of US, EU, and global cGMP regulations
  • Experience with Change Control Review Boards
  • Leadership of Data Integrity Programs
  • Management of Complaints and CAPA processes

Nice-to-have

  • Strong cross-functional communication skills
  • Ability to apply AI to team execution
  • Experience with corporate health authority inspections
  • Demonstrated prioritization and organization skills

Key Requirements

  • Bachelor's degree in engineering or life/physical science
  • Minimum 5 years work experience in Quality Assurance
  • Background in clinical/commercial manufacturing compliance

Work Rights

Not specified

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