Your Role: R&D Quality Assurance AuditorThis role 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 position oversees regulated activities including VICH GL9 standards to support global product approvals for veterinary medicines. By partnering closely with R&D stakeholders, the role proactively drives compliance through the implementation of Elanco Quality Standards, specialized training, and strategic quality input.
Your 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.
What You Need to Succeed (minimum qualifications):- Education: Bachelor's of Science Degree in biology, animal science, pharmacy, or a related field.
- Experience: At least 10 years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies (FDA, USDA, EPA regulated).
- Skills: Deep knowledge of GLP/GCP regulations, proven ability to influence senior scientific leaders, and a strong understanding of risk management and Quality Systems.
What Will Give You the Competitive Edge (preferred qualifications):- Master's in Life Sciences or a Doctor of Veterinary Medicine.
- Society for Quality Assurance RQAP-GLP certification.
- Experience with IACUC, Biosafety Committees, and Health and Safety protocols.
Additional Information:- Location: Fort Dodge, Iowa (On-site Position)
