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)
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
- Multiple relocation packages
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- 9 Employee Resource Groups
- Annual bonus offering
- Up to 6% 401K matching
