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 a Senior Associate, Quality Assurance for External Manufacturing, you will be part of the Elanco Global Quality team, ensuring the quality and compliance of finished drug products manufactured by contract manufacturing organizations (CMOs) and suppliers.

In this role, you’ll be responsible for overseeing product release, maintaining quality systems, and driving compliance with regulatory and internal standards.

Your Responsibilities:


* Lead quality oversight and product release for externally manufactured products including parenterals, solid oral dose forms, non-sterile liquids, premix, APIs, and parasiticides, ensuring all batches meet internal standards, cGMP regulations, and global regulatory requirements prior to distribution.


* Oversee the qualification, onboarding, and lifecycle management of CMOs and suppliers by facilitating cross-functional assessments, executing Quality Plans, and ensuring ongoing compliance through audits, performance reviews, and risk-based monitoring of quality metrics.


* Drive resolution of quality issues at CMOs and suppliers through active investigation support, root cause analysis, and timely implementation of effective CAPAs; escalate high-impact issues appropriately while fostering a collaborative and accountable relationship with partners.


* Review and approve critical quality and technical documentation such as deviations, change controls, process validation protocols and reports, laboratory investigations, and manufacturing technical documents to ensure the validated state of commercial products is maintained throughout their lifecycle.


* Act as a key quality liaison across internal and external stakeholders to support inspection readiness, training initiatives, interpretation of quality standards, and integration of newly acquired or launched products into compliant quality systems and procedures.

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s Degree in Chemistry, Pharmacy, En...