Quality Assurance Regulatory & Cmc Manager

University of Pennsylvania

Philadelphia, Pennsylvania, US
Base: $89,500.00 - $109,500.00 annual rate; bonus/...
Cgmp quality and compliance
Cmc strategy for inds
Batch record review
This role ensures cGMP quality and compliance for the release of investigational cell and gene therapy products for human administration

Job Summary

  • This role ensures cGMP quality and compliance for the release of investigational cell and gene therapy products for human administration.
  • The Manager will define and manage the CMC strategy for INDs, assist in regulatory reporting, and represent the function to external groups.
  • The University offers a competitive benefits package including excellent healthcare, tuition benefits, and generous retirement benefits.

Matching Summary

This role ensures cGMP quality and compliance for the release of investigational cell and gene therapy products for human administration.

Salary

Base: $89,500.00 - $109,500.00 Annual Rate; Bonus/Equity: Not specified; Benefits: Comprehensive medical, prescription, behavioral health, dental, vision, life insurance, tuition assistance, retirement plans, time away from work, long-term care insurance, wellness resources

Skills & Requirements

Must-have

  • cGMP quality and compliance
  • CMC strategy for INDs
  • batch record review
  • deviation investigations
  • FDA regulated industry experience
  • aseptic processing knowledge

Nice-to-have

  • team-oriented contributors
  • highly cross-functional environment
  • supportive work and family benefits
  • continuous quality assurance

Key Requirements

  • Bachelor's degree in Biology or related science
  • 5-7 years of experience in FDA/GMP regulated industry
  • Master's degree strongly preferred
  • Experience managing deviations and leading investigations
  • Project and time management skills
  • Working knowledge of GXPs

Work Rights

Not specified

Tailored Resume

Cover Letter