Quality Assurance Regulatory & Cmc Manager

University of Pennsylvania

Philadelphia, Pennsylvania, US
Base: $89,500 - $109,500 annual; bonus/equity: not...
Cgmp quality and compliance
Regulatory compliance for ind applications
Quality assurance in cell therapy manufacturing
The Manager of the Regulatory and CMC unit plays a critical role in regulatory affairs and quality assurance for investigational cell and gene therapy products at the University of Pennsylvania

Job Summary

  • The Manager of the Regulatory and CMC unit plays a critical role in regulatory affairs and quality assurance for investigational cell and gene therapy products at the University of Pennsylvania.
  • This role involves leadership of a QA team, management of CMC strategy for INDs, and coordination with internal and external collaborators to ensure regulatory compliance and product quality.
  • The University of Pennsylvania offers a competitive benefits package including healthcare, tuition assistance, retirement plans, wellness programs, and professional development opportunities.

Matching Summary

The Manager of the Regulatory and CMC unit plays a critical role in regulatory affairs and quality assurance for investigational cell and gene therapy products at the University of Pennsylvania.

Salary

Base: $89,500 - $109,500 Annual; Bonus/Equity: Not specified; Benefits: Comprehensive healthcare, tuition benefits, retirement plans, wellness programs

Skills & Requirements

Must-have

  • cGMP quality and compliance
  • Regulatory compliance for IND applications
  • Quality assurance in cell therapy manufacturing
  • Supervisory experience managing QA teams
  • FDA inquiry and audit response
  • Batch record review and deviation investigations

Nice-to-have

  • Cross-functional collaboration
  • Project and time management skills
  • Strong analytical and critical thinking
  • Excellent verbal and written communication
  • Flexible work hours including weekends

Key Requirements

  • Bachelor's degree in Biology or related science
  • 5-7 years FDA/GMP regulated industry experience
  • Experience in cGMP facility operations
  • Knowledge of gene therapy manufacturing and testing
  • Experience managing deviations and investigations
  • Master's degree strongly preferred

Work Rights

Not specified

Tailored Resume

Cover Letter