Senior Quality Associate Elanco External Manufacturing (EEM) EMEA (Distribution)

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: To ensure that 3rd Party Manufacturers and Logistics Service Providers (LSPs) are effective and compliant with the relevant regulatory and internal requirements, thereby ensuring that the veterinary medicinal and biocidal products released onto the market are fit for their intended purpose. To drive and maintain improvements in the quality systems and processes, related to 3rd party manufactures, Suppliers and Logistic Service Providers. To provide advice on all quality and compliance matters to ensure retention of the Product and Distribution Licenses.

Your responsibilities:

• Support the qualification and onboarding of Third Parties and Logistics Service Providers in line with GMP/GDP and global quality standards
• Provide Quality input for product launches, qualification, and validation activities
• Manage and support change controls with external partners and internal stakeholders
• Support regulatory submissions and GDP inspections
• Maintain and implement Quality Agreements with suppliers and logistics partners
• Monitor supplier and LSP performance metrics to proactively identify compliance risks
• Support investigations, CAPAs, and quality issue resolution with Third Parties
• Coordinate audits and follow-up actions with suppliers and logistics providers
• Review Product Quality Reviews (PQRs/APRs) and monitor quality trends
• Drive continuous improvement initiatives across quality systems and supplier oversight activities

What You Need to Succeed (minimum qualifications):

• Degree in Science (Diploma, Master’s degree or equivalent) or minimum 10 years equivalent experience in GMP role
• Minimum 5 years’ experience in Quality Assurance within Distribution GDP regulated environments
• Strong knowledge of GMP, GDP, and regulatory requirements for medicinal products
• Experience working with external manufacturers, suppliers, or distribution partners
• Experience within a global organisation and cross-functional environment
• Excellent communication skills and strong command of English

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

• Additional language skills
• Knowledge of Quality Control processes

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 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.