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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.

Purpose:

The purpose of the Clinical Trial Quality Associate – Global Medicines Quality Organization (GMQO) is to support the clinical development and implementation of the strategy for **Good Clinical Practice (GCP)** quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas.

**Primary Responsibilities:** This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

Implement and Manage Quality Systems

+ 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)

Provide Quality Oversight for business area(s)

+ 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.

Audits and Inspections

+ 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.

Partnership with other area(s)

+ 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.

Minimum Qualification Requirements:

+ Bachelor’s Degree - Preferred in a science/technology/health care related field

+ 2+ years' experience within a Good Clinical Practice (GCP) quality organization

Other Information/Additional Preferences:

+ 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

Internal applicants: this position is on the R-Path and part of the Technical Promotion Process.

This position is located at the Indianapolis, IN headquarters and is not approved for remote work.** **A** **minimum of 3 days a week on site is required.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and/or visas for this role.

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 - $148,500

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.

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