PR&D Compliance – Principal Associate - QA
Company: Eli Lilly and Company
Location: Indianapolis
Posted on: March 2, 2026
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Job 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
Keywords: Eli Lilly and Company, Indianapolis , PR&D Compliance – Principal Associate - QA, Science, Research & Development , Indianapolis, Indiana
