Global Quality Auditor Lead

Elanco•Indianapolis, IN

1d•Hybrid

About The Position

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! 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.

Requirements

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 requirements
Top 2 skills: Ability to identify and communicate quality and regulatory risks with technical and strategic insight; strong interpersonal and technical writing skills

Nice To Haves

Demonstrated success in auditing aseptic or sterile manufacturing platforms under FDA, EMA, or similar regulatory oversight
Experience leading or contributing to quality improvement initiatives, such as Six Sigma or Lean projects
Proficiency in identifying compliance trends and translating data into risk-based quality strategies
Ability to build trust and influence across global cross-functional teams and third-party partners
Strong ability to manage conflict, drive resolution, and deliver constructive feedback professionally

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