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 AuditorAs an R&D Quality Assurance Auditor, you will be part of Elanco's R&D Quality Assurance (ERDQA) organization, providing quality oversight and consultative support to Clinical Development and non-clinical research activities. In this role, you'll be responsible for ensuring compliance with global regulatory requirements (GCP/GLP), supporting animal health registrations, and partnering closely with R&D teams and external partners to proactively drive quality and inspection readiness.
Your 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.
What You Need to Succeed (minimum qualifications):- Education: 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.
- Required Experience: 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.
- Top Skills: Strong knowledge of GCP/GLP regulations and quality systems, combined with the ability to influence and partner effectively with senior scientific and business leaders.
What will give you a competitive edge (preferred qualifications):- 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.
Additional Information:- Travel: Up to 20% annually
- Location: Global Elanco Headquarters - Downtown Indianapolis, IN - Hybrid Work Environment
Don't meet every single requirement? Studies have shown underrepresented 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
- Flexible work arrangements
- 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
