CSV Supplier Oversight Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Position Description: The CSV External Services Lead is an individual-contributor Quality technical lead role within the Global Information Systems Quality (GISQ) organization. The role serves as the enterprise subject matter expert (SME) and quality oversight lead for the suppliers and third parties that develop, host, operate, support, or validate Lilly’s GxP computerized systems, and is responsible for: Leading risk-based quality management of computerized system suppliers and third-party service providers across all service models, including commercial off-the-shelf (COTS) software, configured and custom development, Software-as-a-Service (SaaS), Platform-/Infrastructure-as-a-Service (PaaS/IaaS) and cloud hosting, managed IT services, and outsourced CSV/managed-service providers. Owning the computerized system supplier assessment, from risk-based planning and scheduling through assessment execution, reporting, and requalification. Managing audit observations and reports through supplier response, CAPA, verification of effectiveness, and closure, escalating when commitments are not met or residual risk is unacceptable. Defining and approving the quality requirements in Quality Technical Agreements (QTAs) and the quality-relevant terms of Service Level Agreements (SLAs), partnering with Procurement, Legal, and service owners so that GxP responsibilities are clearly allocated and enforceable. Monitoring supplier quality performance against QTAs, SLAs, and KPIs, conducting periodic supplier quality reviews, and directing corrective action when performance deviates from expectations. Seeking and interpreting regulatory expectations for outsourced activities and supplier oversight (e.g., EU GMP Chapter 7 and Annex 11, 21 CFR Part 11, ICH Q9(R1) and Q10, ICH E6(R3)) and translating them into controlled procedures and supporting policies. Representing computerized system supplier oversight during health authority inspections and audits, demonstrating that Lilly retains accountability for outsourced GxP activities. Serving as a point of escalation for GISQ CSQA representatives and business partners on supplier quality matters, including supplier-related deviations, supplier change notifications, and unresolved audit findings. Partnering with Procurement, Legal, Cyber Security, Privacy, and Tech@Lilly sourcing/vendor management to integrate quality requirements into the full supplier lifecycle, from selection and onboarding through exit. Serving as a member of the GISQ Technical Review Board, providing direction on enterprise-wide computer system discussions and coaching/mentoring across the network. Key Objectives/Deliverables: Supplier and Third-Party Quality Oversight Managed-Service Oversight: For outsourced CSV and managed-service providers, oversee the quality obligations within contracts and statements of work (SOWs), supplier performance, service planning, continuity of knowledge and staffing, and transition obligations. Assessments: Oversee the risk-assessment process (on-site, remote, and questionnaire-based assessments), leveraging independent certifications and attestations (e.g., ISO 9001, ISO/IEC 27001, SOC 2 Type II) where appropriate, and issue reports within defined timelines. Assessment Observations and Reports: Classify observations, evaluate supplier responses and CAPA plans, ver…

View the full posting and apply