Overview

Seeking an experienced GLP Quality Assurance professional to support an FDA-regulated test facility. This role serves as the on-site QA representative, with primary responsibility for auditing non-clinical studies and ensuring GLP compliance. This position is 100% site-based with no expected travel to clinical sites or veterinary clinics.

Key Responsibilities

• Serve as the GLP Quality Assurance Unit representative, ensuring compliance with FDA GLP (21 CFR Part 58)
  

• Conduct audits of:
  

  • Study protocols
    

  • In-life phases (as applicable)
    

  • Final study reports and raw data
    

  
  

• Issue audit reports, QA statements, and review CAPAs
  

• Support inspection readiness and host FDA inspections on-site
  

• Provide quality oversight for non-clinical safety studies (internal and external)
  

• Deliver training on GLP and quality standards across R&D
  

• Build strong cross-functional relationships and act as a trusted QA partner, guiding teams toward compliance rather than a purely enforcement-driven approach

Qualifications

• Bachelor’s degree (advanced degree preferred) in Life Sciences or related field
  

• 10+ years of GLP QA experience, including Quality Assurance Unit responsibilities
  

• Strong knowledge of FDA GLP regulations and non-clinical safety studies
  

• Experience auditing protocols, data, and final reports
  

• Proven ability to train, influence, and partner with scientific teams
  

• Experience with quality systems, CAPA, and inspection readiness

Preferred

• RQAP-GLP certification
  

• Experience in animal health or regulated non-clinical environments

Why This Role

High-impact opportunity to help build and maintain a GLP-compliant environment, with a strong emphasis on hands-on auditing, training, and collaborative, service-oriented quality leadership.

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