Global CSQA Representative (R2-R4)

Role Summary

The Global CSQA Representative is responsible for ensuring that their assigned functional areas, projects, and/or systems comply with corporate computer system validation (CSV) standards. This includes providing consultation and interpretation of Corporate Computer Systems Standards, Practices, and Procedures, 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 supported areas. While the primary area of responsibility will align with Global Information Systems Quality (GISQ) needs, a significant portfolio within the Business Units organization is expected, with preference given to candidates who demonstrate strength and proficiency in this subject matter.

Responsibilities

• Maintain Inspectional Readiness: Ensure supported systems are validated in compliance with LQS/LQPs; track quality actions in Quality/CAPA plans; participate in self-inspections, audits, and supplier assessments; keep Inspection Readiness materials current; provide periodic updates to key stakeholders; escalate issues appropriately.
• Deliver Projects, Programs, and Support: Provide consulting and interpretation on LQS/LQPs related to supported computer systems; provide training on CSV topics; partner with Business, Business Quality, and IT to deliver value; review/approve documents per CSV expectations within service levels; engage customers and QA management in risk discussions; ensure suppliers meet quality expectations; escalate quality issues; promote consistency within CSQA.
• Streamline and Continuously Improve: Eliminate non-value added activities; engage in process improvement initiatives (e.g., Six Sigma); identify opportunities for streamlining and simplification; understand external trends affecting supported IT areas.
• Grow Capabilities and Knowledge: Share lessons learned and best practices; act as an engaged team member.

Skills

• Strong oral and written communication, interpersonal skills, and ability to influence and collaborate
• Proficiency with IT systems development life cycle
• Ability to right-size validation based on risk and maintain end-to-end process focus
• Risk management and stakeholder engagement

Qualifications

• Required: Bachelor’s degree in a technology-related field (e.g., Computer Science) or equivalent experience (3+ years in Automation/IT or computer system validation); strong communication and collaboration abilities; proficiency with IT systems development life cycle; proficiency with CSV practices and risk-based validation; ability to manage end-to-end processes.
• Preferred: Understanding of process development/improvement (e.g., Six Sigma); knowledge of multiple Lilly business areas; broad IT technical competency; ability to relate system use to product/patient impact; knowledge of IT Best Practices (e.g., LSEF, ITIL); certifications such as CISA, ISO, ITIL, CSQE (ASQ, QAI).

Education

• Bachelor’s degree in Computer Science or a technology-related field, or equivalent experience (3+ years).