Quality Assurance – Computer System Validation (CSV)

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We pride ourselves on fostering a diverse and inclusive work environment, where 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.

Requirements

• Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards
• Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports
• Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis
• Partner cross-functionally with IT, Engineering, Automation, and Operations to implement and maintain compliant computerized systems
• Support continuous improvement of site Quality Systems through SOP development, training, coaching, and change control management

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