Principal/Sr. Principal - GISQ Computer System Quality Assurance – Mergers and Acquisitions

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: July 15, 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: Join Lilly’s Global Information Systems Quality (GISQ) team and play a pivotal role in shaping the future of healthcare innovation. As a GISQ Computer System Quality Assurance (CSQA) associate for Mergers & Acquisitions (M&A), you will be at the forefront of integrating newly acquired companies into Lilly’s global quality ecosystem. This role ensures that critical computer systems meet regulatory standards while enabling seamless IT integration and business continuity. By maintaining Lilly’s high standards of compliance and operational excellence during M&A activities and ensuring acquired systems align with Lilly’s quality framework, you help safeguard patient safety, regulatory trust, and business agility. Be part of a mission-driven company improving lives worldwide. Position Description The GISQ Computer Systems Quality Assurance role – Mergers and Acquisitions is responsible for assessing and providing oversight of quality for regulated (e.g., GMP) computer systems across multiple Tech@Lilly functional areas and Lilly acquired companies’ computer systems. This high-impact role provides quality consultation and oversight for computer systems quality integration of acquired companies, developing and implementing validation strategies for computer systems ensuring compliance with the external regulatory standards, Lilly IT Quality Management systems and M&A SOPs. This includes partnering with Tech@Lilly, Cybersecurity, and Records Management teams, providing expert consultation on Lilly’s Quality Systems and CSV practices. This position offers the opportunity to drive continuous improvement and the adoption of AI tools in validation. Additionally, mentoring and training others in Computer System Validation (CSV) and M&A support, shaping quality strategy in a dynamic M&A environment. This role provides high visibility across global functions and leadership, allowing to influence the future of digital quality assurance at Lilly and collaborate with cross-functional quality and IT experts. This GISQ CSQA Representative position will be located in US. Responsibilities: Mergers & Acquisitions GISQ Support Function as the primary Information System Quality liaison with acquired companies. Collaborate with Tech@Lilly, CyberSecurity, and Record Management teams on the IT Integration plan. Assess each acquired company's computer system/platform inventory and determine validation strategies. Partner with the Lead Assessor to perform GISQ Assessments. Ensure the IT Integration Team complies with applicable M&A SOPs. Provide oversight as CSQA for high-risk computer systems, as needed. Manage IT Integration M&A IT inspection readiness activities for acquired companies. Consult on M&A IT Integration decommissioning and training services. Train and consult on Lilly IT QMS. Maintain Inspection Readiness Offer expert consulting and interpretation on Lilly Quality Systems, practices, and their relation to internal and external standards and regulations. Lead and direct self-inspections, audits, and assessment activities. Provide technical leadership during serious quality-related issues with computer systems. Ensure corrective actions from audits, deviations, or other sources are appropriate and consistent across functions. Monitor the current state of inspection-readiness and escalate issues appropriately. Drive Continuous Improvement Drive streamlining opportunities and improvements in M&A strategies and processes. Promote the adoption of automation and AI tools to enhance efficiency. Align organizational priorities with corporate direction and external expectations. Pursue opportunities to streamline processes internally and across functions. Address systemic issues across functions and drive improvement activities. Bring external learning back to Lilly by understanding the external environment and best practices. Projects and Programs Understand the M&A environment, and company priorities Understand and maximize business value of Computer System Validation and Computer Software Assurance Understand customer, company, and Quality priorities Provide consulting and right-sizing of CSV activity for major IT programs (e.g. M&A) and/or key issues based on risk and value Influence leadership on validation expectations Grow Capabilities and Knowledge Coach and mentor others in CSV-related roles and M&A support. Enhance capabilities of those performing CSV activities. Align CSV expectations with data integrity and good documentation practice principles. Maintain qualification programs for CSQA roles. Develop training programs to increase understanding and knowledge of CSV. Basic Requirements: Bachelor degree in a science, quality, or technology-related field such as Computer Science, Engineering, Mathematics, or Life Sciences; or equivalent experience 5 years’ experience in IT or computer system validation Experience in Mergers and Acquisitions or CSQA, IT Quality Experience with Computer Systems Validation Strong proficiency with IT systems development life cycle Additional Skills/Preferences: Previous experience in a GxP (e.g. GMP, GLP, GCP) environment Proven leadership and ability to influence including ability to partner in difficult situations Demonstrated strong oral and written communication skills Strong interpersonal interaction skills Understanding of process development and/or improvement (e.g. Six Sigma) Knowledge of Lilly business area and its impact to products and patients Familiarity with IT Best Practices (e.g., LSEF, ITIL, NIST) Ability to work independently and drive a diverse work-team Additional Information: GISQ Computer System Quality Assurance M&A associate must complete CSQA Qualification Program Travel 5% - 10% may be required 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 $63,000 - $162,800 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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