Senior Quality Advisor – R&D Technical Development

Elanco•Indianapolis, IN

6d•Hybrid

About The Position

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.

Requirements

Ph.D. in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field (or equivalent 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.
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.

Nice To Haves

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.

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.