GxP Supplier Quality Lead — CSV & Audits

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 117,000 - 172,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Pension plan

Vacation benefits

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking an External Services Lead to oversee supplier quality for GxP computerized systems. This individual-contributor role leads risk-based quality management across COTS, SaaS, PaaS/IaaS, and managed services, ensuring regulatory alignment and robust supplier oversight.

The role includes owning supplier assessments, directing CAPA processes, and coordinating with Procurement, Legal, and Cyber Security to enforce QTAs and SLAs.

Qualifications

• Bachelor degree in science, engineering, computer science or related field.
• Experience in Computer System Validation, including 21 CFR Part 11 and EU GMP Annex 11.
• Experience planning, leading and reporting assessments of computerized system suppliers.
• Experience authoring or negotiating Quality Technical Agreements with Procurement and Legal.
• Knowledge of cloud/outsourced service models (SaaS, PaaS, IaaS) and GxP compliance.

Responsibilities

• Lead risk-based quality management of computerized system suppliers and third-party service providers.
• Own supplier assessments from planning through reporting and requalification.
• Manage audit observations and reports, coordinating CAPA and verification of effectiveness.
• Define and approve QTAs and SLA requirements in collaboration with Procurement and Legal.
• Monitor supplier quality performance against QTAs and SLAs, and direct corrective actions when needed.
• Prepare for and participate in health authority inspections and supplier oversight activities.

Skills

Quality management

GxP compliance

Supplier management

Regulatory expectations

Audits/inspections

Education

Bachelor degree in science/engineering or related field

Tools

ISO 9001

ISO/IEC 27001

SOC 2 Type II

Job description

Lilly, headquartered in Indianapolis, Indiana, is seeking an External Services Lead to oversee supplier quality for GxP computerized systems. This individual-contributor role leads risk-based quality management across COTS, SaaS, PaaS/IaaS, and managed services, ensuring regulatory alignment and robust supplier oversight.

The role includes owning supplier assessments, directing CAPA processes, and coordinating with Procurement, Legal, and Cyber Security to enforce QTAs and SLAs.