Quality Manager Elanco GmbH/ Elanco Animal Health GmbH

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!

Position Description:

As the central quality contact for Elanco GmbH, Cuxhaven and Elanco Animal Health GmbH (EAH), Monheim organization, the Quality Manager advises, decides, reports, consults and escalates quality matters related to acting as a Marketing Authorization holder to the appropriate management and functional leaders when needed.

The Quality Manager provides independent quality oversight of GxP service providers in scope of the activities mentioned above and supports other responsible person(s) to ensure products meet the quality that customers and the regulators expect.

Functions, Duties, Tasks:


* Ensure that all operations of Elanco GmbH and EAH GmbH related to acting as a Marketing Authorization holder comply with applicable GxP, other applicable company quality standards, local regulations and appropriate quality agreements are in place.


* In partnership with local affiliate Quality and Supply Chain provide Quality Oversight of Elanco co-promotors


* Support other nominated responsible person(s) to fulfill their legal obligations, e.g.

the Qualified Person for Pharmacovigilance (QP PV)


* Demonstrate continuous improvement and minimize risk by a routine self-assessment, corrective & preventative actions (CAPA), use of a Quality Plan and review of metrics


* As a MA holder, ensure a system is maintained products are manufactured in compliance with (EU) 2019/6 and TAMG as applicable, comply to their specification and are distributed in compliance with the specified conditions.


* Act as Quality contact for respective surveillance agencies


* Accountable for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, procedure review & approval, maintenance of the Quality Plan, and recall management.


* Organize, prepare and hold PQR Review board meetings


* Manage agency inspections related to MAH’s activities of Elanco GmbH and Elanco Animal Health GmbH (EAH)


* Manage requests from authorities related to Authorities’ analytical testing of products in the market “Staatlich...