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 Elanco quality system training requirements, and identification of professional development opportunities for the team and self. This also includes ensuring completion of all assigned training by the due dates.

• Manages Manufacturing Investigations, Deviations, Change Controls, and CAPAs, including training employees on reporting requirements, reviewing and approving investigations, ensuring compliance and root cause identification, performing CAPA effectiveness checks, and guiding impact assessments for change controls.

What You Need to Succeed (Minimum Qualifications):

• A BS/BA, or advanced degree is required with more than 10 years in a regulated pharmaceutical/vaccine manufacturing environment.

• At least 5 years of people leadership or department oversight experience (organizational, budgeting, strategy).

• Significant work and theoretical knowledge are required in order to objectively assess procedures and determine the level of compliance, apply appropriate risk assessment, and recommend improvements to improve compliance levels.

What Will Give You the Competitive Edge (Preferred Qualifications):

• Demonstrates proficiency in lean/5S/six sigma methodologies.

• Recognizes and reacts to the significance of data/results.

• Ability to be actively engaged in leadership and professional development of team members.

Additional Information:

• Location: Winslow, Maine

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