Deviation Mentor - Global QC

Location: Indianapolis
Posted on: June 23, 2025

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. Organization Overview: The Global Quality Control - Deviation Mentor plays a critical role within the Analytical Sciences and Quality Control (QC) organization. This individual is responsible for guiding and mentoring analytical and deviation investigators at new QC sites, ensuring high standards in investigation quality and regulatory compliance. In addition to mentoring, the role includes assisting with complex investigations, developing and delivering training, supporting sites in regulatory inspections, and supporting site readiness activities. Responsibilities: Develop and deliver training programs related to deviation investigations and root cause analysis for QC analysts and leaders. Mentor and advise investigators at new QC sites on deviation and analytical investigations, including quality impact assessments, root cause analysis, data evaluation, and technical writing. Guide reviewers and approvers in investigation quality and decision-making. Assist with complex investigations, collaborating cross-functionally as needed. Serve as a technical reviewer and approver for deviation and analytical investigations, including moderate and observation-level deviations. Participate in deviation and change control review boards to ensure quality and consistency prior to approval. Evaluate the quality of approved investigations and contribute to trend analysis and reporting. Coach analysts, technical leads, and deviation owners through investigations and quality processes. Contribute to the development of site metrics and dashboards related to deviation and investigation performance. Maintain qualifications as a lead investigator, and deviation assessor/approver. Support continuous improvement initiatives to align with regulatory expectations and industry best practices. Prepare and coach staff for inspection interactions and participate in regulatory inspections and readiness activities. Assist in integrating global deviation management initiatives into site-level quality practices. Basic Requirements: Bachelor’s or Master’s degree in Chemistry, Biology, Engineering, or a related scientific field. Minimum of 5 years of experience in the pharmaceutical or biotechnology industry. Proven expertise in leading complex root cause investigations. Additional Skills/Preferences: Proven experience in cross-functional teamwork and leadership. Excellent technical writing and critical thinking skills. Strong interpersonal, influencing, and communication skills. Self-driven with effective time management and organizational capabilities. Solid knowledge of cGMPs, regulatory expectations, and quality systems (e.g., TrackWise, PMX, SAP, Q-docs). Background in Technical Services/Manufacturing Science (TS/MS), Engineering, Quality Control (QC), or Quality Assurance (QA) is a plus. Additional Information: Domestic and international travel will frequently be required. This role is located in Indianapolis, IN and is not approved for remote work. 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 $121,500 - $198,000 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

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