Director – Quality Assurance (Project Management)
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 Assurance
As the Quality Assurance Director at Elanco's Clinton site, you will be part of a global leader in pet and farm animal health products, overseeing the quality assurance group supporting food animal manufacturing operations. In this role, you'll be responsible for ensuring regulatory compliance, managing quality issues, developing quality strategies, and driving cross-functional collaboration to meet business and quality objectives; regulations governing manufacturing in this area include 21-CFR-210, 21-CFR-211, 21-CFR-507, 21-CFR-226. The position has approximately 7 direct reports, within a Quality Assurance Organization of approximately 18 personnel.
Your Responsibilities:
Ensure compliance with applicable regulatory bodies by overseeing all aspects of Quality Management, ensuring standards are met, and regularly reporting and assessing performance adequacy.
Manage and support the resolution of quality and technical issues, aligning with global standards, and approving deviations, procedures, protocols, and change controls to maintain regulatory compliance.
Escalate critical or major issues impacting product quality to management following standard procedures, ensuring timely resolution, and supporting the development of the site's Quality Strategy and Planning.
Maintain readiness for Health Authority inspections (PAI, directed, etc.), ensuring GMP follow-up actions for audit/inspection observations are tracked, addressed, and resolved in alignment with quality standards.
Collaborate with Regulatory partners, manufacturing, and supply chain teams to support new product submissions, ensure regulatory commitments are met (e.g., MCSR dates), drive operational excellence strategies, and foster a high-performance, cross-functional partnership culture.
What You Need to Succeed (minimum qualifications):
Education: Bachelor's Degree or equivalent experience in a science-related field (preferred).
Required Experience: A minimum of 10 years of cGMP experience in food, feed, or pharmaceutical manufacturing; 5 years of leadership experience; demonstrated coaching and mentoring skills, strong documentation skills, strong technical skills, effective communication, interpersonal skills and networking skills, ability to organize and prioritize multiple tasks and respond to changing priorities, ability to work independently, proven record of decision making and attention to detail, computer applications, statistical analysis, and creative and innovative problem solving.
Top skills: Strong documentation and technical skills; effective communication and interpersonal abilities.
What will give you a competitive edge (preferred qualifications):
Expertise in Quality Assurance, Quality Control, HACCP, and food/feed safety in regulated environments.
Proven experience with FDA, EMEA inspections, and risk management tools.
Strong understanding of regulatory requirements for global commercial processes.
Proficiency in Microsoft Office, document management, maintenance management, and quality systems.
Additional Information:
Location: Clinton, IN Manufacturing Site
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
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
