CSV Supplier Oversight Lead

Eli Lilly and Company • Us, IN

7d • Onsite

About The Position

The CSV External Services Lead is an individual-contributor Quality technical lead in Lilly’s Global Information Systems Quality (GISQ) organization. The role serves as the enterprise subject matter expert and quality oversight lead for suppliers and third parties that develop, host, operate, support, or validate Lilly’s GxP computerized systems. It leads risk-based quality management across service models including COTS software, configured and custom development, SaaS, PaaS/IaaS and cloud hosting, managed IT services, and outsourced CSV and managed-service providers.

The role owns supplier assessments from planning and scheduling through execution, reporting, requalification, and closure of findings. It defines and approves quality requirements in Quality Technical Agreements and quality-relevant SLA terms, monitors supplier performance, and escalates unacceptable risks or missed commitments. It interprets regulatory expectations for outsourced activities and supplier oversight, translates them into controlled procedures and policies, and represents supplier oversight during health authority inspections and audits.

The position partners across Procurement, Legal, Cyber Security, Privacy, Tech@Lilly sourcing and vendor management, system owners, and Quality groups to integrate quality throughout the supplier lifecycle. It also serves on the GISQ Technical Review Board, provides consultation on supplier-management procedures, and coaches and mentors colleagues. The position is based in Indianapolis, Indiana, and requires travel to support supplier audits, potentially internationally. The role has no direct people-management responsibility.

Requirements

• Bachelor’s degree in science, engineering, computer science/systems, or a pharmaceutical-related field, or equivalent experience.
• Prior role experience in Computer System Validation, including working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, and regulatory expectations for outsourced activities and supplier oversight.
• Prior role experience planning, leading, and reporting assessments of computerized-system suppliers or IT service providers, including managing observations through closure.
• Prior role experience authoring or negotiating Quality Technical Agreements and defining quality-relevant SLA requirements with Procurement and Legal.
• Prior role experience managing supplier or managed-service relationships, including contracts, SOWs, and performance management, without formal people-management responsibility.
• Working knowledge of cloud and outsourced service models, including SaaS, PaaS, IaaS, and managed services, and their shared-responsibility implications for GxP compliance.
• Experience supporting health authority inspections and audits, including coordinating evidence retrieval and defending the company’s position on supplier oversight.
• Sustained ability to contribute and influence at the AVP/IO level and with supplier leadership.
• Strong oral and written communication, negotiation, and interpersonal skills, with the ability to influence and collaborate.
• Ability to focus across multiple processes with an end-to-end viewpoint.
• Must complete Lilly’s CSQA Qualification Program and applicable Lilly auditor qualification before leading supplier audits.

Nice To Haves

• Practical application of IT-control-related certifications, such as CISA, ISO, ITIL, or CSQE (ASQ, QAI).
• Prior experience with Lilly Quality Systems, including deviations, analytical investigations, change, and/or complaints, and third-party risk-management processes.
• Global experience, including oversight of international suppliers and service providers.
• Knowledge of IT best practices, such as LSEF and ITIL, particularly service-level and service-management practices.
• Broad IT technical competency, including emerging technologies such as cloud, machine learning, and artificial intelligence.
• Ability to relate supplier performance and system use to potential impact on products and patients.
• Track record of building resilient supplier relationships through continuity planning, cross-training, and disciplined knowledge transfer.
• Ability to work effectively in a diverse, multicultural environment and adapt communication style accordingly.
• Strong influence-without-authority skills for a cross-functional individual-contributor role.
• Membership and active participation in external forums or organizations.

Responsibilities

• Lead risk-based quality management of computerized-system suppliers and third-party service providers across relevant software, cloud, managed-service, and outsourced CSV models.
• Own supplier assessments from risk-based planning and scheduling through execution, reporting, and requalification.
• Manage audit observations and reports through supplier responses, CAPA, effectiveness verification, and closure; escalate missed commitments or unacceptable residual risk.
• Author, negotiate, approve, and periodically review Quality Technical Agreements and define quality-relevant SLA requirements in partnership with Procurement, Legal, and service owners.
• Monitor supplier quality performance against QTAs, SLAs, and KPIs; conduct periodic supplier quality reviews and direct corrective action when performance deviates.
• Interpret regulatory expectations for outsourced activities and supplier oversight and translate them into controlled procedures and supporting policies.
• Represent computerized-system supplier oversight during health authority inspections and audits.
• Serve as an escalation point for GISQ CSQA representatives and business partners on supplier deviations, change notifications, and unresolved audit findings.
• Partner with Procurement, Legal, Cyber Security, Privacy, Tech@Lilly sourcing/vendor management, and other stakeholders to integrate quality requirements throughout the supplier lifecycle, including selection, onboarding, and exit.
• Oversee quality obligations for outsourced CSV and managed-service providers, including contracts and SOWs, supplier performance, service planning, continuity of knowledge and staffing, and transition obligations.
• Oversee risk-based on-site, remote, and questionnaire-based assessments; use independent certifications and attestations where appropriate and issue reports within defined timelines.
• Ensure supplier changes and subcontractor changes are assessed for impact to the validated state in partnership with the CSV Common Process Lead and system owners.
• Maintain inspection readiness by ensuring supplier qualification records, audit reports, QTAs, and supplier performance evidence are current, complete, and retrievable.
• Track supplier-oversight quality actions and commitments in Quality/CAPA plans and ensure timely completion.
• Provide periodic updates to GISQ leadership and stakeholders on supplier risk profiles, audit-program status, open observations, and emerging supplier risks.
• Provide consultation and interpretation on computer-system procedures related to supplier management and appropriately escalate quality issues.
• Serve as a GISQ/Tech@Lilly process owner for computerized-system supplier-management procedures.
• Coordinate with other Quality organizations and Procurement’s third-party risk processes to harmonize oversight and avoid duplicate audits.
• Maintain periodic touchpoints with strategic suppliers and internal service owners to discuss trends, performance, upcoming changes, and concerns.
• Review and approve documents within agreed service levels or clearly communicate completion timing.
• Improve supplier oversight by right-sizing assessment depth and frequency according to risk and standardizing templates, checklists, and questionnaires by service model.
• Monitor external trends and potential implications for the supplier base and supported IT areas.
• Develop networks with other Quality organizations, share audit and supplier-event lessons learned, coach and mentor colleagues, and benchmark supplier-oversight practices.

Benefits

• Company bonus eligibility, depending in part on company and individual performance.
• Company-sponsored 401(k) eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior