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
The Manager of the Regulatory and CMC unit plays a critical role in the regulatory affairs and quality assurance efforts of the Center for Cellular Immunotherapies (CCI), ensuring cGMP quality and compliance for investigational cell and gene therapy products

Job Summary

  • The Manager of the Regulatory and CMC unit plays a critical role in the regulatory affairs and quality assurance efforts of the Center for Cellular Immunotherapies (CCI), ensuring cGMP quality and compliance for investigational cell and gene therapy products.
  • This role will direct a team of 3-4 quality assurance leads and associates to assure highly effective, team-oriented contributors to CVPF's success, and support effective and efficient continuous quality assurance.
  • Penn offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, and a wide variety of professional development opportunities.

Matching Summary

The Manager of the Regulatory and CMC unit plays a critical role in the regulatory affairs and quality assurance efforts of the Center for Cellular Immunotherapies (CCI), ensuring cGMP quality and compliance for investigational cell and gene therapy products.

Salary

Base: $89,500.00 - $109,500.00 Annual Rate; Bonus/Equity: Not specified; Benefits: Excellent healthcare, tuition, retirement, professional development

Skills & Requirements

Must-have

  • cGMP quality and compliance
  • CMC strategy for INDs
  • batch record review
  • deviation investigations
  • CAPA management
  • FDA regulated industry experience

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

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