Senior Associate, Quality Assurance - External Manufacturing

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Job Title: Senior Associate, Quality Assurance - External Manufacturing
Location: Indianapolis, IN, Midwest United States, USA

Company: Elanco
Industry Sector: Agribusiness
Industry Type: Input Retail, Cooperative and Related Crop Services
Career Type: Manufacturing/Production
Job Type: Full Time

Job Description: 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 collaboration and problem-solving skills

What will give you a competitive edge (preferred qualifications):

Experience with sterile injectables, solid oral dose, and non-sterile liquid manufacturing
Track record of managing quality oversight of contract manufacturing organizations (CMOs)
Hands-on experience with deviation investigation, CAPA, risk management, and batch release
Familiarity with U.S. regulatory bodies (e.g. FDA, EPA) and inspection readiness activities
Proven ability to operate in a global, cross-functional team environment

Additional Information:

Travel: Up to 20% annually
Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment; Moving to downtown Indianapolis, IN October, 2025

Don'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 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

Elanco 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

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Job Post Date: 06/22/25