Quality Assurance Advisor - R&D

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.

• 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.

• 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.

• 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.

• Location:
  
  Fort Dodge, Iowa (On-site Position)

• 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

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