Computer Systems Quality Assurance Associate; Global

Organization Overview

Global Information Systems Quality (GISQ) serves as the Quality Assurance Unit for global computer systems and provides governance, application, and oversight of the IT Quality Management System as defined in the global Computer Systems Validation procedures.

The Computer Systems Quality Assurance (CSQA) role ensures assigned functional areas, projects, and systems comply with corporate Computer Systems Validation (CSV) standards. Responsibilities include interpreting and applying global CSV procedures, overseeing and approving CSV deliverables, maintaining awareness of internal and external CSV requirements, and ensuring supported areas remain inspection‑ready.

This CSQA Role will provide quality oversight for systems owned by the Customer Technology Innovation organization in Tech@Lilly, including regulatory and statistics systems.

Key Objectives/Deliverables:

• Ensure supported systems remain validated per global policies and procedures.
• Track all quality actions and commitments in CAPA.
• Lead or participate in self‑inspections, audits, and supplier assessments to assess validation status.
• Keep all inspection‑readiness materials current and accurate.
• Provide periodic updates to key stakeholders.
• Escalate issues as appropriate.

• Provide consulting and interpretation of global CSV procedures for supported systems.
• Deliver IT Quality–related training as needed.
• Partner cross‑functionally with Business, Business Quality, and Tech@Lilly to deliver value.

• Understand and align with customer, company, and Quality priorities.
• Review and approve documents within expected quality standards and timelines.
• Engage partners' and Quality management in appropriate discussions of risk.
• Ensure suppliers of computer systems or services meet quality expectations.
• Escalate computer system quality issues to the appropriate stakeholders.
• Strive for promote consistency within the GISQ organization.

• Eliminate non‑value added activities in order to focus on activities which continuously improve assurance of quality.
• Identify opportunity for streamlining and simplification and assist in developing improved solutions.
• Understand external trends and potential ramifications for the supported IT area(s).

• Share lessons learned and best practices with others
• Support teammates by sharing experience, providing backup coverage, consulting, mentoring new CSQA Representatives, etc.

• Bachelor's degree – Preferred in a technology related field (i.e. Computer Science) or High School Diploma with 4 years of IT or Quality experience in a regulated industry

• Prior experience in IT systems development experience or QA
• Proficiency with the software development lifecycle
• Strong verbal and written communication, interpersonal interaction skills, and collaborate
• Proficiency with Computer Systems Validation and demonstrated ability to right‑size validation based upon risk
• Understanding of process development and/or improvement methodologies
• Knowledge of multiple Lilly business areas
• Broad IT technical competency
• Knowledge of IT best practices (e.g., ITIL)
• Practical application of IT‑control related certifications (e.g., CISA, ISO, ITIL, CSQE (ASQ, QAI))

• Travel 0‑5%
• All CSQA Representatives must complete Lilly's CSQA Qualification Program, including AI CSQA Certification.
• This role is located at our corporate center in Indianapolis, IN and is required to be onsite with the flexibility to work from home 4 days per month.
• 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.

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