Advisor-Quality Assurance

Iowa Ag; Fort Dodge, Northern (IA, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Elanco seeks a qualified R&D Quality Assurance Auditor at the Fort Dodge, IA site. The role provides quality oversight for GLP and vGCP-compliant non-clinical safety studies, acting as ERDQA representative to the R&D Site Lead Team.

You will audit and ensure site adherence to FDA GLP (21 CFR Part 58) and VICH GL9 standards. Responsibilities include sponsor oversight, CAPA management, and training development for R&D and ERDQA teams to foster a culture of quality.

Qualifications

• Education: Bachelors in biology, animal science, pharmacy, or related field.
• Experience: 10+ years in quality oversight for veterinary clinical/safety studies (FDA, USDA, EPA regulated).
• Skills: deep knowledge of GLP/GCP; ability to influence senior scientists; risk management and Quality Systems.

Responsibilities

• Lead regulatory execution for GLP/GCP compliance at the Fort Dodge site.
• Plan and oversee internal and third-party audits to ensure regulatory adherence.
• Sponsor oversight for non-clinical safety and clinical studies at third parties.
• Maintain and improve QMS; drive CAPA investigations and actions.
• Deliver compliance training to R&D and ERDQA teams.

Skills

GLP knowledge

GCP knowledge

Quality systems

Stakeholder influence

Education

Bachelor's in biology/related field

Master's in Life Sciences or DVM

Job description

**At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.** **At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.** **Making animals' lives better makes life better - join our team today!** **Your Role: R&D Quality Assurance Auditor** 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. **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) Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.To apply please click on APPLY TO THIS POSITION