Manager, Gmp Inspection Management

RayzeBio

Indianapolis, IN, US
Base: $124,449 - $150,803; bonus/equity: + incenti...
Fully remote
Bachelor's degree in engineering or life science
5-7 years quality assurance experience
4 years direct gmp audit/inspection leadership
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 will be responsible for managing the Self-Inspection Program, Pre-Licensure Inspection Readiness Audits, QP audits, and Health Authority Inspections.
  • The position offers a competitive salary range of $124,449 - $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, and wellbeing support

Skills & Requirements

Must-have

  • Bachelor's degree in engineering or life science
  • 5-7 years Quality Assurance experience
  • 4 years direct GMP audit/inspection leadership
  • Knowledge of US, EU, and rest-of-world cGMP regulations
  • Experience hosting FDA, EMA, or regulatory authority inspections

Nice-to-have

  • Strong background in clinical/commercial manufacturing compliance
  • Excellent writing and oral communication skills
  • Demonstrated prioritization and organization skills
  • Ability to exercise sound judgment in decision-making

Key Requirements

  • Minimum 5-7 years QA work experience
  • Minimum 4 years direct GMP audit/inspection experience
  • Bachelor's degree in engineering, biology, biochemistry, or chemistry

Work Rights

Not specified

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