Global Quality Auditor Lead

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: Global Quality Auditor Lead

As a Global Quality Auditor Lead, you will be part of the Elanco Global Quality Compliance and Auditing (EGQCA) organization, supporting Elanco Animal Health through internal and external audits focused on aseptic pharmaceutical manufacturing.

In this role, you’ll be responsible for ensuring that operations across commercial supply chains, including contract manufacturers and internal sites, comply with global regulatory expectations, Elanco’s quality standards, and industry best practices, particularly in sterile/aseptic environments.

Your Responsibilities:


* Conduct end-to-end audits of aseptic pharmaceutical manufacturing operations, including internal sites and external partners, to evaluate compliance with current Good Manufacturing Practices (cGMP), Elanco quality standards, and applicable global regulations


* Develop detailed audit plans, lead pre-audit risk assessments, and produce comprehensive audit reports that highlight findings, assess risk level, and provide clear recommendations to stakeholders at all levels


* Mentor and train new auditors, supporting their qualification process and contributing to the continuous improvement of audit processes and audit team capabilities


* Lead risk assessments across commercial supply chains—integrating audit findings and operational risks to influence compliance strategy, quality oversight, and mitigation plans


* Support business continuity and product supply by auditing critical aseptic suppliers, participating in mock inspections, and conducting due diligence evaluations for new partnerships and acquisitions

What You Need to Succeed (minimum qualifications):


* Education: Bachelor’s Degree (or equivalent work experience) in physical or biological sciences, engineering, or other technical area, or combination of education and experience


* Required Experience: Minimum of 5 years of auditing experience in aseptic pharmaceutical manufacturing, with a deep understanding of sterile product processes and global compliance requ...