R&D Quality Assurance Auditor

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns in the US

8-week parental leave

Annual bonus offering

Up to 6% 401K matching

Job summary

A global animal health leader is seeking a Quality Assurance Advisor for R&D in Fort Dodge, Iowa. The role focuses on ensuring compliance with federal regulatory standards while overseeing quality assurance processes for non-clinical safety studies. Ideal candidates will have a Bachelor's degree in a relevant field along with a minimum of 10 years of experience in quality oversight roles. Strong expertise in GLP and GCP regulations is essential. The position offers a competitive salary and comprehensive benefits.

Qualifications

• 10+ years of experience in a quality oversight or monitoring role for veterinary clinical and safety studies.
• Experience with FDA, USDA, EPA regulations.
• Master’s in Life Sciences or a Doctor of Veterinary Medicine preferred.

Responsibilities

• Execute the site Quality Assurance program in compliance with FDA GLP and VICH GL9 standards.
• Plan and conduct internal and third-party audits.
• Manage the Quality Management System and oversee CAPA actions.
• Act as a primary liaison for regulatory authority inspections.

Skills

Deep knowledge of GLP/GCP regulations

Proven ability to influence senior scientific leaders

Strong understanding of risk management

Experience with compliance training

Education

Bachelor's of Science Degree in biology, animal science, pharmacy, or a related field

Job description

Quality Assurance Advisor - R&D page is loaded## Quality Assurance Advisor - R&Dlocations: Fort Dodge, IAtime type: Full timeposted on: Posted Todayjob requisition id: R0024568**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 Advisor**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)*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 matchingElanco 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 statusElanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose CSR framework – all to advance the health of animals, people and the planet. Learn more at .