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. 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!

Quality Assurance Specialist External Manufacturing

As Quality Assurance Specialist External Manufacturing, you will support Elanco's regional Americas external manufacturing network, acting as a quality subject matter expert for products manufactured by third parties. In this role, you will help ensure compliance with current Good Manufacturing Practice (cGMP), local regulatory requirements, and Elanco quality standards while enabling batch release, product launches, and continuous improvement across the network.

Your Responsibilities:

• Lead quality oversight of third-party manufacturers and suppliers across the Americas region, ensuring products are manufactured and released in compliance with current Good Manufacturing Practice (cGMP), local regulations, and Elanco quality standards.

• Review and approve deviation investigations, Corrective and Preventive Actions (CAPA), change controls, complaints, batch documentation, and finished product release documentation.

• Maintain and approve quality procedures, Master Batch Records, and supporting documentation required for regulatory requests and ongoing quality operations.

• Support technology transfers, validation, stability activities, training on quality topics, and cross-functional technical questions from internal teams and external partners.

• Monitor quality performance through Key Performance Indicators (KPIs), self-assessments, and quality plans, and escalate compliance risks and trends to management.

What You Need to Succeed (minimum qualifications):

• Bachelor's Degree in Pharmacy, Biochemistry, or a related technical discipline.

• A minimum of 5 years of experience in quality assurance in a Good Manufacturing Practice (GMP)-regulated environment.

• Hands-on experience with batch release, deviation management, Corrective and Preventive Actions (CAPA), change control, and multi-market quality regulations.

• Working knowledge of quality systems and tools including Veeva, SAP, and Microsoft Office; intermediate to advanced English proficiency.

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

• Spanish proficiency.

• Experience with technology transfers, validation, and stability studies.

• Experience managing batch release and documentation with a high level of accuracy and attention to detail.

• Demonstrated ability to take ownership of new challenges and deliver with urgency in a regulated environment.

• Proven track record of building strong relationships and delivering customer-focused solutions for internal and external stakeholders.

Additional Information:
Travel: 0%
Location: São Paulo, Brazil — Hybrid, 3 days per week in the office.

Don't meet every single requirement? Studies have shown underrecognized 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 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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.