Senior Associate, Quality Assurance - External Manufacturing

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. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet and our enterprise.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 Associate, Quality Assurance - External ManufacturingAs an Senior Associate, Quality Assurance - External Manufacturing, you will be part of the Elanco External Manufacturing (EEM) team to ensure quality compliance and oversight across Elanco's externally manufactured products and suppliers. In this role, you'll be responsible for managing supplier relationships, ensuring product release readiness, and driving continuous improvement and regulatory compliance.Your Responsibilities:Provide end-to-end quality oversight and batch release support for externally manufactured Elanco products, including APIs, sterile injectables, solid oral dose forms, non-sterile liquids, and parasiticides, ensuring alignment with regulatory and internal quality requirementsLead the qualification, onboarding, and ongoing monitoring of CMOs and suppliers to ensure adherence to current GMP standards, the Elanco Quality Manual, and global regulatory expectationsManage quality-related issue resolution at CMOs/suppliers, including escalation of critical concerns, facilitation of root cause analysis, and implementation of timely and effective CAPAs to ensure product integrity and supply continuityReview and approve key quality system documentation such as deviations, change controls, CAPAs, complaints, and laboratory investigations to support product lifecycle management and compliance readinessCollaborate with cross-functional teams-including Regulatory, Technical Services, Supply Chain, and Manufacturing Operations-to ensure audit readiness, inspection support, and continuous improvement in external manufacturing performanceWhat You Need to Succeed (minimum qualifications):Education: Bachelor's Degree in a relevant field (science, pharmacy, engineering) or equivalent GMP industry experienceRequired Experience: A minimum of 5 years of experience in pharmaceutical quality, manufacturing, or technical operationsTop 2 skills: Strong cGMP and regulatory compliance knowledge; effective collaboration and problem-solving skillsWhat will give you a competitive edge (preferred qualifications):Experience with sterile injectables, solid oral dose, and non-sterile liquid manufacturingTrack record of managing quality oversight of contract manufacturing organizations (CMOs)Hands-on experience with deviation investigation, CAPA, risk management, and batch releaseFamiliarity with U.S. regulatory bodies (e.g. FDA, EPA) and inspection readiness activitiesProven ability to operate in a global, cross-functional team environmentAdditional Information:Travel: Up to 20% annuallyLocation: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment; Moving to downtown Indianapolis, IN October, 2025Don'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 packagesTwo weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)8-week parental leave9 Employee Resource GroupsAnnual bonus offeringFlexible work arrangementsUp to 6% 401K matchingElanco 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