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.

Job Summary

The Quality Systems Associate performs a wide variety of duties including, but not limited to, management of controlled documents Quality Management Systems (QMS) performance oversight, data collection and reporting of quality metrics for management reviews and monthly quality metrics performance. This position will be responsible for managing documentation, data management systems. This position assists with the oversight of internal audit program and Quality Plan.

Job Responsibilities

·       Oversee the management of controlled documents throughout their lifecycle for GxP and non-GxP Operations.

·       Establish and maintain document control workflows and work instructions (e.g., Veeva document routing guides).

·       Manage job descriptions for all Avid personnel to assure inspection readiness.

·       Manage room support during audits or regulatory inspections, as required

·       Provide audit support during Site Self-inspection and external audits/inspections, including managing support rooms and ensuring timely responses.

·       Manage the transfer of paper documents to paperless systems, as applicable

·       Provide user management of data management systems and provide quality support to users (e.g., Veeva).

·       Provide guidance on Good Quality Practices (GQP) and ensure adherence to regulatory requirements.

·       Generate monthly quality performance metrics using Excel PivotTables to visualize and assure timely closure of outstanding quality actions.

·       Lead document migration projects and implement digital transformation initiatives to streamline workflows and reduce manual processes.

·       Support oversight of external manufacturing organizations (i.e., creating TrackWise records for external action tracking)

·       Support GxP training program updates in SuccessFactors, maintaining compliance with training requirements.

·       Write or revise SOPs associated with document control or areas of responsibility

·       Assist in or conduct GxP investigations (e.g., complaints, deviations, CAPA, and effectiveness checks)

·       Collaborate with cross-functional teams to ensure audit readiness and continuous improvement of quality processes.

·       Identify any improvement opportunity within responsible areas and provide action plans, as required

·       Other duties as assigned.

Job Qualifications

·       Bachelor’s degree

·       Minimum of 2 years of experience in Pharmaceutical Quality Assurance

Additional Skills/Preferences:

·       Demonstrate experience in quality metrics reporting and audit preparation

·       Have experience in Good Quality Practices

·       Strong knowledge of MS Word with form generation and password protected functionality

·       Strong knowledge of MS Excel (e.g. formula, pivot tables and macro functionality)

·       Detail-oriented, ability to work independently, highly motivated.

·       Strong interpersonal, verbal and written communication skills

·       Ability to work with colleagues

·       Ability to work independently and escalate issues when necessary

·       Experience with TrackWise, Veeva, and SuccessFactors for document control and training compliance.

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

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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