R&D Quality Assurance Auditor

Role Summary

R&D Quality Assurance Auditor provides quality oversight and consultative support for Elanco’s R&D Clinical Development organization, serving as the GLP Test Facility Quality Assurance Unit to ensure regulatory compliance for non-clinical safety studies. Based at the Fort Dodge site, the role oversees regulated activities including VICH GL9 standards to support global product approvals for veterinary medicines. By partnering with R&D stakeholders, the role drives compliance through the implementation of Elanco Quality Standards, specialized training, and strategic quality input.

Responsibilities

• Regulatory Execution & Leadership: Execute the site Quality Assurance program in strict compliance with FDA GLP (21 CFR Part 58) and vGCP (VICH GL9) standards, while serving as the ERDQA representative to the R&D Site Lead Team.
• Comprehensive Auditing: Plan and conduct end-to-end internal and third-party audits—including protocol, in-life, data, and final report reviews—to ensure total adherence to regulatory requirements and Elanco Quality Systems.
• Sponsor & System Oversight: Provide critical Sponsor oversight for non-clinical safety and clinical studies conducted at third parties, while maintaining quality standards for R&D GXP equipment, systems, and site procedures.
• Quality Management & CAPA: Manage the Quality Management System (QMS) by authoring site Quality procedures, leading investigations into deviations, and overseeing the implementation and suitability of Corrective and Preventive Actions (CAPA).
• Stakeholder Engagement & Training: Act as a primary liaison for regulatory authority inspections and external stakeholders, while developing and delivering compliance training to R&D and ERDQA teams to foster a culture of quality.

Qualifications

• Required: Education: Bachelor's of Science Degree in biology, animal science, pharmacy, or a related field.
• Required: Experience: At least 10 years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies (FDA, USDA, EPA regulated).
• Required: Skills: Deep knowledge of GLP/GCP regulations, proven ability to influence senior scientific leaders, and a strong understanding of risk management and Quality Systems.
• Preferred: Master’s in Life Sciences or a Doctor of Veterinary Medicine.
• Preferred: Society for Quality Assurance RQAP-GLP certification.
• Preferred: Experience with IACUC, Biosafety Committees, and Health and Safety protocols.