The Manager for Quality Engineering will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of the RayzeBio Indianapolis facility
Job Summary
The Manager for Quality Engineering will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of the RayzeBio Indianapolis facility.
Essential duties include reviewing and approving commissioning and qualification lifecycle documentation, ensuring compliance with the site validation master plan, and supporting facility start-up operations.
Benefits include health coverage, wellbeing support, financial well-being and protection, and work-life benefits such as paid time off and leaves of absence.
Matching Summary
The Manager for Quality Engineering will be responsible for providing Quality oversight of qualification and validation activities and change control for the startup and continuing operations of the RayzeBio Indianapolis facility.
Salary
Base: $124,449 - $150,803; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
Quality oversight of validation
Commissioning and qualification lifecycle
cGMP regulations and guidance
Quality Risk Management principles
Process validation per standards
Nice-to-have
Transformative radiopharmaceutical therapies
Nimble, pioneering spirit
Multidisciplinary team collaboration
Continuous improvement goals
AI to improve team execution
Key Requirements
Bachelor's degree in engineering or life/physical science
Minimum 5 years in Quality Assurance
Minimum 3 years direct validation experience
Knowledge of US, EU, and rest-of-world cGMP regulations