Global Quality Auditor Lead
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Role Summary
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.
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
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 requirements
- Top 2 skills: Ability to identify and communicate quality and regulatory risks with technical and strategic insight; strong interpersonal and technical writing skills
Preferred Qualifications
- 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
Additional Information
- Location: Global Elanco Headquarters – Downtown Indianapolis, IN - Hybrid Work Environment
- Travel: Up to 50% domestic and international travel annually; trips typically 1–2 weeks in duration, sometimes on short notice