Full Description

At 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. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Position Description: The PR&D Compliance Principal Associate supports the audit and inspection programs across Product Research & Development (PR&D). This role plans, coordinates, and executes cross‑functional preparation and live inspection activities (frontroom and backroom); ensures seamless communication and execution amongst all parties. This role monitors and drives closure of commitments arising from audits/inspections and escalate to Senior Leadership as needed. This role is responsible for monitoring and reporting on the overall performance and health of the audit/inspection programs. This role will lead continuous improvement initiatives to improve the performance and health of the audit/inspection programs. Additionally, this role plans and executes Site Self- Inspections. Key Responsibilities: Serve as a PR&D point of contact during audits and inspections, ensuring effective coordination and communication across internal and external stakeholders. Lead PR&D planning, organization, and execution of inspection‑readiness activities, including preparation for Internal Corporate Audits, Good Clinical Practice Sponsor and Site Inspections, Good Manufacturing Practice Inspections, and Pre-Approval Inspections (PAI). Coordinate and manage responses to inspection and audit requests, findings, commitments, and follow‑up actions. Prepare and deliver training material to support audit and inspection activities. Identify, monitor, and escalate inspection‑readiness gaps, compliance risks, and quality‑system issues. Oversee tracking, integration, and continuous improvement of audit/inspection commitments and related quality‑system processes. Develop and deliver training, outreach, and readiness‑support activities for PR&D and cross‑functional partners. Support and enhance the site self‑inspection program and associated compliance activities. Collaborate with cross‑functional and external partners to strengthen audit/inspection processes and support externally sponsored research quality oversight Basic Requirements: 5–7 years of experience in pharmaceutical audits and inspections Ability to work 6-8 hours of computer usage Proven experience coordinating audit and inspection responses Working knowledge of cGMPs, GCP, and clinical trial processes Demonstrated technical competency in Quality Systems Strong problem‑solving abilities with effective interpersonal, collaboration, and leadership skills Demonstrated project‑management capability with strong prioritization skills Education Requirements: Bachelor’s Degree in Life Sciences, Engineering, or related field. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does 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. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly