Eli Lilly and Company · 16 hours ago
Clinical Trial Quality Associate
Indianapolis, IN
Full-time
Hybrid
Entry Level
$65K/yr - $148K/yr
2+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana. They are seeking a Clinical Trial Quality Associate to support the clinical development and implementation of Good Clinical Practice (GCP) quality systems and activities to ensure compliance and quality oversight.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Develop and maintain area-specific procedures, tools, and resource materials; review and approve quality system documents as assigned
Ensure clear accountability for regional/affiliate quality system requirements
Recommend new or revised quality system documents
Advise on training for implementation and documentation
Provide guidance on interpreting and applying external requirements and standards
Manage deviations, change controls, and Notifications to Management (NTM), ensuring proper documentation, escalation, and closure
Consult on root cause analysis and CAPA, including review and approval as needed
Contribute to risk assessments, audit planning, and quality plans based on identified gaps
Conduct self-inspections and drive actionable improvements
Support local implementation of quality systems
Assist with external party management (e.g., third-party organizations, business partners)
Monitor compliance with quality system documents; Anticipates gaps and proactively proposes solutions
Communicates and escalate issues to management as appropriate
Ensure implementation of regional/affiliate Quality Plans and track progress
Provide updates to quality and business owners
Drive process simplification and improvement initiatives
Coordinate quality improvement projects
Review metrics and trending to improve processes and compliance
Compile and maintain compliance metrics (e.g., periodic report metrics)
Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports)
Track completion of deviations, change controls, CAPA, audit responses
Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses)
Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)
Ensure completion of audit corrective action plans and timely resolution
Leads and/or supports readiness activities in collaboration with business partners
Serve as primary quality consultant for business areas
Partner with business units to ensure robust quality controls
Shares key learning to drive simplification and replicate best practices
Collaborates with other quality groups and build a strong quality network
Establishes good working relationships with assigned business area(s)
Actively participate in team, business and quality related meetings
Support issue resolution and escalation using a risk-based approach
Support key projects as assigned
Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable
Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned
Perform IT Business Quality as defined in Computer System Policies and Procedures
Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality
Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems
Qualification
Required
Bachelor's Degree - Preferred in a science/technology/health care related field
2+ years' experience within a Good Clinical Practice (GCP) quality organization
Preferred
Strong knowledge of GCP and quality systems in regulated environments
Proven project and time management skills
Effective written and verbal communication; ability to influence others
Skilled at prioritizing and managing multiple tasks
Strong problem-solving, critical thinking, and analytical abilities
Flexible and adaptable with strong interpersonal skills across diverse environments
Excellent organizational and self-management skills
Experience in functional areas such as medical writing, regulatory affairs, or clinical trial management
Ability to work independently and collaboratively in a global setting
Benefits
Company bonus (depending, in part, on company and individual performance)
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
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2026-01-25
2026-01-24
2026-01-23
Company data provided by crunchbase