Computer Systems Quality Assurance Associate (Global)
About The Position
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: 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. Position Description: 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.
Requirements
- 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
- 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.
Nice To Haves
- Prior experience in IT systems development experience or QA
- Proficiency with the software development lifecycle
- Strong verbal and written communication, interpersonal interaction skills, and ability to influence 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))
Responsibilities
- Maintain Inspection Readiness
- 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.
- Deliver Projects, Programs, and Support
- 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 and promote consistency within the GISQ organization.
- Streamline and Continuously Improve
- 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).
- Grow Capabilities and Knowledge
- Share lessons learned and best practices with others
- Support teammates by sharing experience, providing backup coverage, consulting, mentoring new CSQA Representatives, etc.
Benefits
- 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).
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
