Global Quality Auditor Lead

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.

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
• 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

Qualifications

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

Benefits

• Elanco Benefits and Perks: Comprehensive benefits package focusing on financial, physical, and mental well-being
• 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
• Took up to 6% 401K matching