PR&D Compliance – Principal Associate - QA

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 escalates 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.

• 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 elevate 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.

• 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

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 (  ) 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,…