Senior Third Party Quality Assurance Specialist, Elanco 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.

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, Suppliersand 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)


* Minimum 5 years’ experience in Quality Assurance within GMP/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 ...