R&D Quality Assurance Auditor

Elanco•Fort Dodge, IA

2d•Onsite

About The Position

This 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.

Requirements

Bachelor's of Science Degree in biology, animal science, pharmacy, or a related field.
At least 10 years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies (FDA, USDA, EPA regulated).
Deep knowledge of GLP/GCP regulations, proven ability to influence senior scientific leaders, and a strong understanding of risk management and Quality Systems.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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).
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.