Manager, Quality Assurance

Zse68

Santa Monica, CA, US
Base: $129,556.80 - $194,335.20; bonus/equity: sho...
Onsite
Cgmp compliance management
Quality management system oversight
Batch record review and release
The Manager, Quality Assurance supports and maintains compliance with the Quality Management System and applicable regulatory requirements for cell therapy products

Job Summary

  • The Manager, Quality Assurance supports and maintains compliance with the Quality Management System and applicable regulatory requirements for cell therapy products.
  • The role provides day-to-day oversight of Quality Assurance activities and contributes to risk assessment and continuous improvement initiatives across multiple sites.
  • The position offers a competitive salary range with bonus and equity opportunities, comprehensive benefits, and a flexible in-person working environment.

Matching Summary

The Manager, Quality Assurance supports and maintains compliance with the Quality Management System and applicable regulatory requirements for cell therapy products.

Salary

Base: $129,556.80 - $194,335.20; Bonus/Equity: Short-term incentive bonus and equity-based long-term incentive program; Benefits: Retirement plan, paid vacation and holidays, paid leaves, medical, prescription drug, dental, and vision coverage

Skills & Requirements

Must-have

  • cGMP compliance management
  • Quality Management System oversight
  • Batch record review and release
  • Deviation and CAPA management
  • Cross-functional team collaboration
  • Regulatory inspection support

Nice-to-have

  • Strong organizational skills
  • Problem-solving and prioritization
  • Microsoft Office proficiency
  • Adaptability to fast-paced environment
  • Experience with Quality Control and Facilities

Key Requirements

  • Bachelor’s degree in Biological Sciences or related field
  • Minimum 5+ years industry experience in GMP environment
  • Master’s degree with 3+ years experience or PhD with 1 year experience
  • Strong knowledge of global regulatory requirements (US, EU, ROW)
  • Experience with deviations, CAPAs, investigations, and change control
  • Experience supporting batch release and product disposition
  • Familiarity with audit processes and regulatory inspections

Work Rights

Not specified

Tailored Resume

Cover Letter