Quality Associate- External Manufacturing NA

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!

This position is accountable for Quality oversight and lifecycle management of assigned Elanco finished drug products; API; contract manufacturing organizations (CMO’s) and suppliers ensuring that Elanco products meet all legal and internal requirements.

This role will actively collaborate with quality, regulatory, technical services, operations, and supply chain counterparts to support quality document reviews/approvals and batch release.

Your Responsibilities:


* Provide Quality Oversight & release activities for Elanco Externally Manufactured Medicinal and Non-Medicinal products.  This may include but not limited to the following:  parenteral, solid oral dose, non-sterile liquid, premix, API, and EPA/parasiticide products.


* Manage and support positive CMOs / Suppliers selection and on-boarding of CMO’s / Suppliers with assurance of compliance with the regulatory, cGMP requirements and the Elanco Quality Manual / Directives


* Manage and support positive CMOs / Suppliers relationships.  Facilitates open communication and cooperation with high integrity.


* Manage and support the resolution of issues at CMOs/Suppliers, escalates issues appropriately and timely and drive corresponding continuous improvement initiatives.


* Guide internal functions within Elanco and external partners (e.g training, issue resolution, interpretation of standards, inspection readiness, etc.)


* Drive the utilization of Risk Management principles for CMOs/Suppliers oversight and monitor CMOs / Suppliers QA performance metrics and reports.


* Ensure Quality Plans are established and executed appropriately for assigned API CMOs/Suppliers while providing support for new API launches/acquisitions to ensure compliant systems and procedures are in place to manage new products.


* Partner with technical services & manufacturing operations to assure that CMO deviations are compliant, root cause and CAPA plans are appropriate and implemented in a timely manner.


* Develop and execute approved quality procedures (SOP’s) applicable to the ...