Elanco · 1 day ago
R&D Quality Assurance Auditor
Indianapolis, IN
Full-time
Hybrid
Senior Level
5+ years expElanco is a global leader in animal health dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. The R&D Quality Assurance Auditor will provide quality oversight and consultative support to Clinical Development and non-clinical research activities, ensuring compliance with global regulatory requirements and partnering closely with R&D teams.
ManufacturingPetSupply Chain Management
Responsibilities
Plan, conduct, and report Quality oversight and audit activities for veterinary Good Clinical Practice (GCP) clinical studies and Good Laboratory Practice (GLP) non-clinical safety studies conducted internally and at third-party sites
Provide sponsor oversight for outsourced GLP studies, including protocol and final report reviews, and collaborate with study teams to ensure regulatory compliance
Issue audit reports, QA statements, and assess corrective and preventive actions (CAPAs), including independent follow-up to ensure effective resolution
Execute process audits (self-inspections) of internal R&D quality system processes and support preparation for regulatory authority inspections
Deliver quality and compliance training to R&D and Quality partners and serve as a trusted quality advisor to the R&D organization
Qualification
Required
Master's degree in a life science (e.g., biology, animal science, pharmacy) with 5+ years of relevant experience, OR a Bachelor's degree in a life science with 10+ years of relevant experience in the animal health industry
A minimum of 5-10 years of experience providing quality oversight or auditing of veterinary clinical and/or non-clinical safety studies regulated by FDA, EPA, USDA, or OECD
Strong knowledge of GCP/GLP regulations and quality systems, combined with the ability to influence and partner effectively with senior scientific and business leaders
Preferred
Society for Quality Assurance (SQA) RQAP-GLP certification
Experience supporting or participating in regulatory authority inspections
Proven experience developing and delivering compliance training to diverse audiences
Strong background in risk assessment and risk management tools
Experience with IACUC, Biosafety Committee, and Health & Safety oversight activities
Benefits
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
Flexible work arrangements
Up to 6% 401K matching
Company
Elanco
Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.
5001-10000 employees
H1B Sponsorship
Elanco has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
Funding
Current Stage
Public CompanyTotal Funding
$252.86MKey Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M
Leadership Team
Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
Justine Conway
Global Head of Business Development and External Innovation
Recent News
2026-01-03
2025-12-18
Company data provided by crunchbase