Manager, Gmp Inspection Management

RayzeBio

Indianapolis, IN, US
Base: $124,449 - $150,803; bonus/equity: + incenti...
Fully remote
Gmp inspection readiness
Health authority inspections
Self-inspection program
The Manager, GMP Inspection Management provides management of activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures and global cGMPs

Job Summary

  • The Manager, GMP Inspection Management provides management of activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures and global cGMPs.
  • Leads site inspection readiness efforts about preparing the Indianapolis site for health authority inspections and internal corporate audits.
  • Benefits include Health Coverage, Wellbeing Support, Financial Well-being and Protection, and Work-life benefits.

Matching Summary

The Manager, GMP Inspection Management provides management of activities for Site Quality Operations in accordance with RayzeBio policies, standards, procedures and global cGMPs.

Salary

Base: $124,449 - $150,803; Bonus/Equity: Additional incentive cash and stock opportunities; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • GMP inspection readiness
  • Health Authority Inspections
  • Self-Inspection Program
  • Regulatory Surveillance
  • cGMP regulations

Nice-to-have

  • Transformative radiopharmaceutical therapies
  • Multidisciplinary team collaboration
  • Pioneering spirit
  • Oncology innovation

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter