Sr. Principal - Global Quality Systems Lead

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: March 25, 2026

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. Responsibilities The Sr Principal (R4) – Global Quality Systems Lead will provide oversight and support of QMS processes under Global Process Ownership for non-Quality owned processes. The role additionally ensures alignment with the greater Quality Management System (QMS) in terms of strategy, infrastructure, and business tools. This role is essential in maintaining the integrity and evolution of the process framework by developing connections, standards, and governance to support commercial and Clinical Supply functions. The role supports the QMS Pillar leads for the health, management, and reporting across the Operational Controls pillar of the QMS framework. Additionally, the GQS Lead will support QMS excellence by supporting the aligning of processes with business priorities, ensuring compliance, and driving quality improvements. Key Objectives/Deliverables: Support and provide oversight for Global Process Owners (GPOs) of non-Quality-owned processes to deliver process excellence in the Pillars of the QMS framework, including the development, review, and approval of Quality Systems documents. Provide consulting support to GPOs, Communities of Practice, Area Process Owners, and Network areas on interpretation and implementation of Lilly global quality systems. Support the GQS structured governance and monitoring model to deliver excellence beyond Quality-owned processes across the framework. Support and conduct Management Review for determining the health of the QMS process ecosystem. Lead and/or support the assessment, development and implementation of global quality projects in support of continual Global Quality System improvements. Consult with Lilly manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, and other functions to educate on the quality system. Proactively work with Global Process Owners to ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends, and scientific principles. Ensure the Global Standard, Processes, Practices, Trainings, and implementation tools are implemented and maintained according to regulatory, industry, and company expectations. Implement and continuously improve governance that results in prioritization, decisions at the right level, and enables QMS ease of execution for required changes. Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. Help define a common set of global effectiveness and efficiency measures to drive end-to-end QMS health, enable desired performance, and build capability expertise. Partner with document owners to obtain potential risks associated with document changes, including regulatory non-compliance, process interruptions, or misalignment between global entities. Develop strategies and contingency plans to mitigate these risks. Support the monitoring of performance metrics, report, and provide insights to inform decision-making to drive further improvements. Support the development of the GPO / APO community to collaborate on proposed improvements and deepen the knowledge of the associated processes and tools. Actively collaborate with enterprise-wide teams on standardized global business processes. Actively engage in external organizations and industry organizations to monitor policy changes for regulatory/external environments and advocate/influence quality-related policies and regulatory requirements. Basic Qualifications Education: Bachelor’s Degree or equivalent in scientific field (e.g., Chemistry, Bio-chemistry), engineering, or related field. Experience: Strong knowledge of cGMP and quality systems with a minimum of 7 years of direct cGMP experience. Demonstrated experience in one or more of the following areas or modalities: Quality Control Labs Cell and Gene Therapy Parenteral Manufacturing Demonstrated learning agility to learn new modalities, QMS areas, and new technologies. Knowledge of Lean and continuous improvement methodologies to develop and continuously improve processes. Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills. Proficiency in planning and carrying out tasks with a great degree of independence, and as part of a team, with minimal supervision and ability to travel. Demonstrated ability to communicate and deliver constructive feedback to customers, including oral, written and presentation communication skills. Demonstrated ability to develop business presentations and effectively communicate the concepts to a multiple range of personnel. Previous regulatory inspection readiness and inspection execution experience Proficient with the usage of the MS Office suite (e.g. Word, Excel, PowerPoint, Access, Project, Visio). Additional Skills/ Preferences Experience in the following quality systems: Quality Risk Management Process and Equipment Validation Cleaning and Sterilization GMP Utilities Sterility Assurance Bioburden Controls Formal training in Lean and Continuous improvement methodologies Formal training in Quality Risk Management Detailed knowledge of US and European GMP’s, ICH, PIC/S, and WHO Continuing education / master’s degree or higher in science related field (e.g., Chemistry, Bio-chemistry). Previous facility or area start up experience, including equipment and process validation support. Additional Information Location Ability to travel (10%) to sites or conferences Requires visits to manufacturing sites. Ability to attend external training courses, conferences or association meetings. Fluent in English; additional languages are also recommended. This is a hybrid position though must be able to be based at a Lilly facility (Indianapolis IN, Lebanon IN, RTP NC, Concord NC, Kinsale Ireland, Sesto Italy, Fegersheim France) with flexibility for some 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 $115,500 - $169,400 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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