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: Senior Quality Advisor – R&D Technical Development
As a Quality Advisor, you will be part of Elanco’s R&D Quality Assurance organization, providing global quality leadership and GMP compliance guidance to support technical development, product registration, and successful product launches. In this role, you will partner closely with R&D, Technical Services, Engineering, and external partners to ensure compliant, risk-based, and fit-for-purpose solutions that enable innovation while meeting global regulatory expectations.
Your Responsibilities:
Provide end-to-end quality oversight for equipment, facilities, utilities, and computerized systems, including review and approval of commissioning and qualification documentation (IQ/OQ/PQ), ensuring systems are designed, installed, and operated in alignment with GxP requirements and validated user needs.
Partner with global R&D, Technical Services/Manufacturing Science (TS/MS), Engineering, and project teams to apply scientific and technical expertise in developing practical, risk-based, and customer-oriented solutions to complex development, scale-up, and process quality challenges.
Establish and execute quality and compliance strategies across development programs, including scientific review and approval of GxP documentation (pre-clinical, clinical, CMC, protocols, reports, investigations, and development materials) to support regulatory submissions and product registration.
Ensure global inspection readiness by conducting and supporting internal audits, self-inspections, and third-party oversight (CMOs, CROs, suppliers), managing Quality Agreements, driving CAPA effectiveness, and coordinating preparation for regulatory authority inspections.
Build and maintain strong cross-functional relationships and influence stakeholders across R&D, Quality, Engineering, and external partners, providing training, guidance, and leadership to drive compliant decision-making and successful project execution without direct authority.
What You Need to Succeed (minimum qualifications):
Education: Ph.D. in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field (or equivalent experience).
Required Experience: Minimum of 5 years of experience in Quality Assurance, Quality Control, or a related technical area within pharmaceutical, biologics, vaccine, or animal health development/manufacturing.
Top 2 skills: Deep expertise in global GMP/regulatory compliance (FDA, EMA, MHRA/VMD, etc.) and strong influencing skills to drive outcomes across cross-functional teams without direct authority.
What will give you a competitive edge (preferred qualifications):
Experience in vaccine, animal health, or biotherapeutic (large molecule) development within an R&D Quality environment.
Hands-on experience with equipment and computerized system qualification, including development and approval of IQ/OQ/PQ protocols and reports.
Proven experience supporting global regulatory submissions and CMC development through registration.
Strong background in quality risk management and inspection readiness.
Auditing experience and advanced quality or regulatory certifications.
Additional Information:
Travel: Up to 10%
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
