Overview
This role supports animal health research and development by providing quality oversight and consultative support across clinical and non-clinical activities. The position is heavily focused on Good Clinical Practice (GCP) auditing of veterinary clinical sites, with additional responsibilities supporting internal lab/process audits and regulatory inspection readiness. This individual will play a key role in hosting FDA inspections and ensuring compliance across R&D operations.

Key Responsibilities

• Plan and conduct GCP audit activities for veterinary clinical studies (e.g., protocol, in-life, data, and final report audits) in alignment with VICH and applicable regulatory standards
  

• Provide sponsor oversight for outsourced studies, including third-party vendor audits and review of study deliverables
  

• Support GLP compliance through protocol and final report reviews for non-clinical safety studies conducted externally
  

• Prepare, issue, and follow up on audit reports, observations, and corrective/preventive actions
  

• Conduct internal process audits (e.g., data management, archiving, monitoring, quality systems)
  

• Lead and coordinate inspection readiness activities and host regulatory inspections (including FDA) at R&D headquarters and clinical sites
  

• Deliver training on quality and regulatory compliance topics; develop training materials as needed
  

• Provide quality oversight of site quality systems and contribute to procedural development
  

• Partner cross-functionally with R&D, quality, and external stakeholders to ensure compliance with global regulatory requirements
  

• Escalate risks and compliance issues appropriately and provide strategic quality guidance

Qualifications

• Bachelor’s degree in life sciences (e.g., biology, animal science, pharmacy) required; advanced degree preferred
  

• 10+ years of experience in GCP and/or GLP quality assurance within animal health, pharmaceutical, or related industries
  

• Strong experience auditing veterinary clinical studies and supporting regulatory submissions (FDA, USDA, EPA)
  

• Demonstrated experience hosting or supporting regulatory inspections
  

• Proven ability to deliver compliance training and influence cross-functional stakeholders
  

• Solid understanding of quality systems, risk assessment, and regulatory frameworks
  

• Experience with computer system validation is a plus

Preferred

• RQAP-GLP certification
  

• Experience with IACUC, biosafety, or health and safety programs

What You’ll Bring

• Deep expertise in GCP auditing with the ability to operate independently
  

• Strong communication and stakeholder management skills
  

• A proactive, service-oriented approach to quality that enables and guides the business
  

• Confidence in leading inspection readiness and interacting with regulatory authorities

This is a high-impact role in a growing R&D quality organization, ideal for someone who thrives in a collaborative environment and brings strong GCP auditing experience along with inspection leadership capability.

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