Manager, Quality Assurance (Process Team)

Elanco•Fort Dodge, IA

1d•Onsite

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: Manager, QA (Process Team) As a Manager, QA (Process Team), you will be part of Elanco Animal Health’s Quality Assurance organization, providing leadership to ensure GMP compliance and technical excellence across manufacturing process teams. In this role, you will drive a proactive quality culture by developing talent, leading quality systems, and partnering with operations to deliver compliant, risk-based, and efficient manufacturing outcomes.

Requirements

Bachelor’s Degree in a science-related field (e.g., Biology, Chemistry)
A minimum of 5 years of experience in regulated pharmaceutical or vaccine manufacturing
Strong GMP/regulatory knowledge (FDA/USDA, aseptic processing) and leadership capability in developing technical teams

Nice To Haves

Experience with SAP, Veeva, and Microsoft Office tools
Prior experience with APHIS/USDA submissions and Outline of Production review
Knowledge of Lean/Six Sigma methodologies
Experience influencing cross-functional teams and driving quality culture initiatives
Strong background in audit readiness and regulatory inspections

Responsibilities

Lead and develop a high-performing QA team, focusing on technical capability, problem-solving, and independent quality oversight
Provide QA oversight across process teams (Filling, Bacterins/Media, Virus/Cell, Blending/Equipment Prep, Quality Control) ensuring GMP compliance
Manage quality systems and lifecycle events (Deviations, CAPAs, Change Controls) within Veeva, ensuring timely and compliant execution
Support audits (internal, corporate, regulatory) and lead investigation, root cause analysis, and CAPA effectiveness
Drive operational excellence through Gemba walks, quality metrics, and cross-functional collaboration to improve Right First Time (RFT) performance