Manager, Quality Engineering

RayzeBio

Indianapolis, IN, US
Base: $124,449 - $150,803; bonus/equity: + incenti...
Fully remote
Quality oversight of qualification and validation
Commissioning, qualification, and validation
Cgmp regulations knowledge
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.
  • Review and approve commissioning and qualification lifecycle documentation associated with manufacturing site facilities/equipment/and utilities.
  • The starting compensation range for this role is $124,449 - $150,803 for a full-time employee.

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 qualification and validation
  • Commissioning, qualification, and validation
  • cGMP regulations knowledge
  • Risk assessment review and approval
  • Equipment and system onboarding quality review

Nice-to-have

  • Pioneering spirit of emergent biotech
  • Transformative radiopharmaceutical therapies
  • Collaboration at the heart of everything
  • Continuous improvement goals and projects

Key Requirements

  • Bachelor's degree in engineering or life/physical science
  • Minimum 5 years of Quality Assurance experience
  • Minimum 3 years of direct validation experience
  • Familiarity with Quality Risk Management principles
  • Knowledge of US, EU and rest-of-world cGMP regulations

Work Rights

Not specified

Tailored Resume

Cover Letter