PR&D Compliance – Principal Associate - QA
About The Position
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.
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
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
Benefits
- 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).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
