Senior Global Quality Auditor

Senior Global Quality Auditor – Eli Lilly and Company Join to apply for the Senior Global Quality Auditor role at Eli Lilly and Company. At Lilly, we unite caring with discovery to make life better for people around the world. Lilly is a global healthcare leader headquartered in Indianapolis, Indiana, and employs scientists worldwide to develop life‑changing medicines. Position Brand Description The Senior Principal Associate – Quality Auditor is part of the Global Quality Auditing and Compliance (GQAAC) division and provides quality assurance through internal and external audits. The role ensures GXP operations by Lilly comply with company standards, policies, procedures and current regulatory requirements. Key Objectives / Deliverables Schedule, prepare, conduct, and report Global Quality audits and assessments of research and commercial operations, internally and externally, to evaluate compliance with company standards and regulations. Participate in mock inspections as appropriate. Lead or participate in the risk assessment of research and commercial operations, integrating audit findings to influence actions within GQAAC and relevant business areas. Escalate significant compliance issues or risks identified during audits or risk assessments. Meet requirements outlined in quality standards, manuals, policies, and procedures. Global Quality – Business Related Responsibilities Identify the need and drive revisions of GQAAC quality system documents when appropriate; participate or lead the preparation and review of standards, policies, procedures, and guidelines. Lead the preparation of organizational metrics and trending of audit findings when required. Provide advice to research and manufacturing operations regarding interpretation of corporate and regulatory GXP requirements. Establish and maintain relationships with relevant regulatory authorities, supporting regulatory inspections as needed. Provide technical expertise for quality and compliance education to customers. Influence internal and external customers and partners when improvement needs are identified. Continuous Improvement Related to Title Participate in continuous improvement initiatives to ensure compliance within a changing regulatory landscape. Represent assigned processes in broader change and transformation initiatives. Partner with risk assessors to innovate and simplify audit processes, including risk‑based audit programs. Enable implementation of GQAAC management and technical strategies. Personal Development Maintain strong interpersonal and communication skills with auditees and business areas. Complete required training identified in the Individual Learning Plan. Stay aware of industry trends and regulatory agency interpretations of GXP requirements. Seek self‑development opportunities and share knowledge with teammates. Mentor others in implementing GXP requirements. Participate or lead divisional improvement efforts, including Six Sigma projects. Act as a proactive coach for others within the organization. Minimum Requirements Bachelor's Degree – preferably in physical or biological sciences, or another technical area. Minimum of five (5) years of experience related to Pharmacovigilance or the pharmaceutical industry. Additional Preferences Experience working with third‑party organizations. Ability to analyze detailed technical scientific information and assess risk and impact in a global context. Ability to interpret and apply regulations, regulatory guidance, codes, and public expectations, and recommend compliance changes. Excellent interpersonal and communication skills. Experience in working on a global team and sharing knowledge. Proficiency with computers and data management in databases. Strong analytical and problem‑solving skills. Ability to manage multiple complex projects simultaneously. Systematic approach to self‑safety and audit team safety. Ability to work under pressure with frequent interruptions and changing priorities. Project management experience and ability to think from a process perspective. Collaboration within a global team environment. Deliver constructive feedback and high‑level customer service. Influence and manage change and conflict. Pragmatic decision‑making ability. Other Information Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 40% (duration 1–2 weeks), sometimes on short notice. We’re proud to be an EEO Employer and do not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 – $187,000. Full‑time equivalent employees are also eligible for a company bonus (depending on company and individual performance). Lilly offers a comprehensive benefit program, including 401(k) eligibility, pension, vacation, medical, dental, vision, prescription drug benefits, flexible benefits such as healthcare and/or dependent day care, life insurance, death benefits, time‑off and leave of absence benefits, and well‑being resources such as employee assistance programs and fitness benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion. #J-18808-Ljbffr