Manager, Gmp Inspection Management

RayzeBio

Indianapolis, IN, US
Base: $124,449 - $150,803; bonus/equity: + incenti...
Fully remote
5-7 years qa experience
4 years direct gmp audit experience
Bachelor's degree in engineering or life science
The role leads site inspection readiness efforts for the Indianapolis site preparing for health authority inspections and internal corporate audits

Job Summary

  • The role leads site inspection readiness efforts for the Indianapolis site preparing for health authority inspections and internal corporate audits.
  • Candidates must have a minimum of 5-7 years of work experience in Quality Assurance with at least 4 years of direct experience leading GMP audits.
  • The position offers competitive compensation ranging from $124,449 to $150,803 along with comprehensive benefits including medical, dental, vision, and 401(k) plans.

Matching Summary

The role leads site inspection readiness efforts for the Indianapolis site preparing for health authority inspections and internal corporate audits.

Salary

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

Skills & Requirements

Must-have

  • 5-7 years QA experience
  • 4 years direct GMP audit experience
  • Bachelor's degree in engineering or life science
  • Knowledge of US EU cGMP regulations
  • Experience hosting FDA EMA inspections

Nice-to-have

  • Strong leadership and communication skills
  • Experience with clinical commercial manufacturing
  • Ability to work in laboratory environment
  • High attention to detail and judgment

Key Requirements

  • Bachelor's degree in engineering or life science
  • Minimum 5-7 years QA experience
  • Minimum 4 years GMP audit/inspection experience
  • Knowledge of US EU rest-of-world cGMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter