Sr. Principal Associate

Sr. Principal Associate - Global Quality Auditing and ComplianceApply for the Sr. Principal Associate - Global Quality Auditing and Compliance role at Eli Lilly and CompanyAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana, working to discover and bring life-changing medicines, improve disease understanding, and give back through philanthropy and volunteerism.Key ResponsibilitiesLead or participate in planning, scheduling, preparing, conducting, and appropriately escalating compliance issues, and reporting audits, assessments, and due diligence of GMP operations to assess the level of compliance with established standards and current regulations and guidelines.Lead or participate in risk assessments and mock regulatory inspections of GMP operations to assess compliance and readiness to meet standards and regulations.Interpret and apply Lilly standards, regulations, guidance, and industry standards to identify compliance risks and maintain comprehensive knowledge of applicable regulations, technical knowledge, and training.Provide technical input and recommendations to audit observation reports during the Audit Review Board meetings.Exhibit ethical behavior during audits, ensuring integrity, objectivity, and confidentiality; recuse oneself when conflict of interest or lack of competency exists.Demonstrate interpersonal skills relevant to auditing: listening, questioning, tact, conflict handling, clear communication, evaluation, judgment, conclusions, business understanding, problem identification, audit principles, and time management.Lead or participate in continuous improvement of the GQAAC quality system and other GQAAC organizational priorities.Participate in continuous improvement of the global quality system and other corporate priorities as requested.Establish and maintain relationships with relevant business units, providing audit-related advice, interpreting Lilly global quality standards, and offering inspection readiness assistance.Participate and/or support GQAAC self‑assessments or regulatory inspections.Complete required training and qualifications identified in your Learning Plan and remain current on regulatory and industry trends.Serve as a mentor and coach for others within the GQAAC organization and attend training courses, conferences, or association meetings to share knowledge.Minimum RequirementsMinimum of five (5) years of experience related to the pharmaceutical industry.Additional PreferencesAbility to work safely and ensure self‑safety and the safety of others.Strong working knowledge of global regulations and guidelines (e.g., FDA, EU, ICH, ISPE, PIC/s) for GMP operations and the ability to interpret and apply regulatory and guidelines.Prior auditing experience, including auditor certification by an external body (e.g., ASQ Quality Auditing).Capacity to produce high‑quality results across multiple projects through effective prioritization and working under short deadlines.Ability to deliver timely and professional oral and written communications with precision and clarity at all organization levels.Excellent personal skills: motivation, self‑management, commitment, teamwork, open‑mindedness, flexibility, and ability to work well with others.Strong project management skills to manage projects at various stages and multitask effectively.Ability to maintain a flexible work schedule and adapt quickly to audit program priorities and other business priorities.Working knowledge of Microsoft Office 365 suite and other business programs (e.g., document management systems, quality management systems).Education RequirementsMinimum bachelor's degree (or equivalent education and/or work experience) in physical or biological sciences, engineering, or another technical area.TravelDomestic and international travel is required to fulfill these responsibilities. Must be able to travel up to 50%, sometimes on short notice.EEO StatementLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( for further assistance. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#J-18808-Ljbffr