Global Quality Auditor Lead
Elanco
Full-time
Remote friendly (Indianapolis, IN)
United States
Operations
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
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
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
Skills
- Auditing
- Regulatory compliance
- Quality risk assessment
- Sterile/aseptic manufacturing
- Technical writing
- Cross-functional collaboration
Education
- Bachelor’s Degree in physical or biological sciences, engineering, or related technical field (or equivalent experience)
Additional Requirements
- 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