Quality Assurance Auditor GCP /R&D

Quality Assurance Auditor - GCP /R D Apply Now Applied To save a job sign in or get started

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10183536 Posted today Back Greenfield, IN, US Scientific Bachelors Degree Full Time, Direct Hire $90,000+/year Experienced (Non-Manager) On-site Biotechnology/Pharmaceuticals First Shift (Day) Greenfield, IN, US $90,000+/year Experienced (Non-Manager) Full Time, Direct Hire Biotechnology/Pharmaceuticals On-site Scientific Bachelors Degree First Shift (Day) Apply Now Applied Job details 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. 10183536 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.

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