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.

Position Description:

This Computer Systems Quality Assurance role will be responsible for supporting the expansion of Lilly's Enterprise Resource Planning Systems and associated applications to new and existing manufacturing sites. You will deliver quality oversight to ensure your assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards.  You will provide consulting and interpretation of Corporate Computer Systems Standards and Practices (LQS/LQPs), providing oversight for CSV execution (including approving CSV documents per corporate standards/practices), maintaining awareness of corporate and external standards as they relate to CSV, and assurance of inspection readiness within your supported areas.  

Key Objectives/Deliverables:

Maintain Inspectional Readiness

Ensure supported systems are validated in compliance with LQS/LQPsEnsure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plansParticipate in self inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understoodEnsure all Inspection Readiness materials (e.g. Tier 1-4) are current and appropriateProvide periodic updates to key stakeholdersEscalate issues appropriately

Deliver Projects, Programs, and Support

Provide consulting and interpretation on LQS/LQPs as related to the supported computer systemProvide training to customer areas on CSV-related topics as neededPartner with Business, Business Quality, and IT customer areas to deliver business valueUnderstand customer, company, and Quality prioritiesReview/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completedEngage customers and QA management in appropriate discussions of risk managementEnsure suppliers of computer systems or services meet quality expectationsEscalate computer system quality issues to the appropriate personsStrive for and promote consistency within the CSQA Organization

Streamline and Continuously Improve

Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality.  This may include engagement in Six Sigma projects and other process improvement activities.Identify opportunity for streamlining and simplification and assist in developing improved solutionsUnderstand external trends and potential ramifications for the supported IT area(s)

Grow Capabilities and Knowledge

Share lessons learned and best practices with othersAct as an engaged team memberContinually develop yourself as an SME in computer system quality, maintain awareness of the regulatory landscape and keep up-to-date with technology (e.g., AI/ML).

Minimum Requirements:

Bachelor (4 yr College) degree in a technology-related field such as Computer Science; or equivalent experience (i.e., 3+ years’ experience in Automation/IT or computer system validation)Demonstrated strong oral and written communication, interpersonal interaction skills, and ability to influence and collaborateProficiency with IT systems development life cycleProficiency with Lilly Computer Systems Validation and demonstrated ability to right-size validation based upon riskAbility to focus across multiple processes (end-to-end viewpoint)

Additional Preferences:

Understanding of process development and/or improvement (e.g. Six Sigma)Knowledge of multiple Lilly business areasBroad IT technical competencyAbility to relate system use to potential impact to products and patientsKnowledge of IT Best Practices (e.g., LSEF, ITIL)Practical application of IT-control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

Other Information:

QA Representative must complete CSQA Qualification Program

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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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