Director, Quality Operations

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!

Your Role: Director, Quality Operations

The Quality Operations Director at the Winslow site provides comprehensive leadership for the Quality Operations team, covering strategic direction, administrative management, and technical expertise.

Their oversight spans the entire manufacturing process, from incoming inspection to product distribution, encompassing key areas such as cell culture, fermentation, downstream processing, packaging, labeling, and laboratory operations.

This role is crucial for ensuring market release of only top-quality products, achieved through effective staff management and rigorous adherence to regulatory, corporate, and site quality standards.

As a Director, you will drive continuous improvement initiatives, foster a culture of quality excellence, and ensure both operational efficiency and full regulatory compliance.

Your Responsibilities:


* Leads and oversees all aspects of Quality Operations, including developing and implementing SOPs, providing technical guidance and training, managing budgets, ensuring compliance with regulations and Elanco standards, escalating quality issues, overseeing documentation practices, and fostering a culture of continuous improvement within a high-performing team.


* Provides comprehensive Quality oversight of all manufacturing and operational processes, including finished product release, conducting audits and walkthroughs, managing event reporting and resolution, guiding documentation practices, coordinating contamination risk mitigation, and collaborating with Sterility Assurance on improvements.


* Manages all aspects of supplier quality, including audit planning and follow-up, maintaining the supplier qualification list, conducting risk assessments, collaborating with stakeholders on supplier selection and approval, overseeing change controls and specification maintenance, and ensuring compliance of incoming materials.


* Oversees and implements the department's training program, including curriculum development and review, collaboration with Operations, compliance with Ela...