Senior Quality Advisor – R&D Technical Development

Role Summary

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. 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.

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.

Qualifications

• Required: Education: Ph.D. in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field (or equivalent experience).
• Required: 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.
• Required: 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.
• Preferred: Experience in vaccine, animal health, or biotherapeutic (large molecule) development within an R&D Quality environment.
• Preferred: Hands-on experience with equipment and computerized system qualification, including development and approval of IQ/OQ/PQ protocols and reports.
• Preferred: Proven experience supporting global regulatory submissions and CMC development through registration.
• Preferred: Strong background in quality risk management and inspection readiness.
• Preferred: Auditing experience and advanced quality or regulatory certifications.

Additional Requirements

• Travel: Up to 10%
• Location: Global Elanco Headquarters - Downtown Indianapolis, IN - Hybrid Work Environment