Elanco · 1 day ago
Senior Quality Advisor – R&D Technical Development
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 Senior Quality Advisor will provide global quality leadership and GMP compliance guidance to support technical development, product registration, and successful product launches, while partnering closely with various teams to ensure compliant and effective solutions.
ManufacturingPetLogisticsSupply Chain Management
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
Qualification
Required
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
Preferred
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
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