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Lilly Associate/Sr. Associate - Clinical Quality Assurance in Indianapolis, Indiana

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 35,000 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.

Associate/Sr. Associate - Clinical Quality Assurance


The Senior Clinical Quality Associate serves as an integral role within the global Quality Assurance (QA) function in ensuring Good Clinical Practices (GCP) compliance. Under the direction of the Associate Director, Clinical Operations QA, this individual executes and supports the continuous improvement efforts within the scope of the GCP Quality Management System (QMS).

  • Assures GCP QMS compliance by providing independent verification through self-inspections, reviews, gap assessments and ensuring the resolution of quality-related issues as consistent with regulatory expectations

  • Supports GCP issue escalation to ensure that specified events, significant GCP quality related issues are escalated to appropriate levels of quality management in a timely manner

  • Reviews investigations, ensures the adequacy of Root Cause analyses and provides consult to Investigation owners

  • Provides oversight on CAPA development and follow-through to ensure GCP Compliance

  • Ensures documentation is compliant with GCP and Good Documentation Practices and is consistent with other policies and procedures

  • Develops and reviews SOPs to ensure GCP Compliance

  • Provides training and consultant to clinical research teams with the intent to foster understanding and compliance with SOPs, GCP, and process improvements

  • Monitors and drives quality events to completion within established due dates

  • Initiates, reviews and monitors change management activities

  • Assists the GCP external quality audit program by evaluating clinical investigational sites to oversee the progress of a clinical trial and to ensure that it is conducted, recorded and reported in accordance with the protocol, standard operating procedures, and applicable GCPs standards

  • Assists to lead the GCP Regulatory Inspections preparedness and success by managing the back room.

  • Establishes internal and external GCP Quality Metrics by preparing and generating reports for Quality Management Review (QMR)

  • Supports oversight of third-party organizations (TPOs) for clinical research projects through external quality audit plans and management of TPO (Vendor) program

  • Contributes to and supports Quality Plan objectives for GCP QMS improvements

  • Manages GCP Document Management, including but not limited to: SOPs (Standard Operating Procedures), Audit Documentation

  • Assists with Regulatory Intelligence Monitoring, as needed

  • Demonstrates a commitment to TEAM Lilly

  • Other projects as assigned

Basic Qualifications:

  • 4 year degree such as BS or BA degree with a minimum of three-years GCP/Clinical Research experience, or High School diploma with a minimum of 5 years of GCP/Clinical Research experience

  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Skills/Preferences:

  • Strong knowledge of GCP regulations and relevant ICH guidelines

  • Experienced with clinical investigation site/vendor audits and regulatory inspections

  • Meeting facilitation and project management skills

  • Ability to simplify complex processes/problems and propose alternate solutions

  • Ability to identify and manage risks to project timelines

  • Ability to assess processes and workflows for their effectiveness and make improvements, as necessary

  • Ability to work independently and escalate issues, when necessary

  • Excellent communication and interpersonal skills

  • Excellent problem solving and decision-making ability

  • Ability to prioritize, multi-task while demonstrating attention to detail

  • Experienced with GCP training requirements

  • Excellent computer skills (e.g. Word, Excel, PowerPoint, Teams)

Additional Information:

  • Ability to travel in US up to 20%

  • Lilly currently anticipates that the base salary for this position could range from between $61,500 to $132,500 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.

  • As a condition of employment with Eli Lilly and Company in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).