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 Manufacturing

As 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 requirements


* Lead the qualification, onboarding, and ongoing monitoring of CMOs and suppliers to ensure adherence to current GMP standards, the Elanco Quality Manual, and global regulatory expectations


* Manage 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 continuity


* Review and approve key quality system documentation such as deviations, change controls, CAPAs, complaints, and laboratory investigations to support product lifecycle management and compliance readiness


* Collaborate 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 performance

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s Degree in a relevant field (science, pharmacy, engineering) or equivalent GMP industry experience


* Required Experience: A minimum of 5 years of experience in pharmaceutical quality, manufacturing, or technical operations


* Top 2 skills: Strong cGMP and regulatory compliance knowledge; effective colla...