Senior CSV Supplier Quality Lead

BioSpace; Indianapolis (IN); On-site; USD 117,000 - 172,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Lilly seeks a CSV External Services Lead within GISQ to provide quality leadership for suppliers and third parties that develop or host GxP computerized systems. This individual-contributor role owns risk-based supplier assessments, manages observations and CAPAs, and ensures QTAs and SLAs reflect proper GxP responsibilities.

Travel is required to support supplier audits, and the position is based in Indianapolis, Indiana.

Qualifications

• Bachelor-level degree or higher in a science, engineering, computer science, or pharmaceutical-related field.
• Experience with Computer System Validation (CSV) and GxP regulatory expectations.
• Experience planning, leading, and reporting assessments of computerized system suppliers or IT service providers.
• Experience authoring/negotiating Quality Technical Agreements and defining SLA requirements.
• Experience managing supplier or managed-service relationships without direct people-management responsibility.

Responsibilities

• Lead risk-based quality management of computerized system suppliers and third-party providers across service models.
• Own supplier assessments from planning through execution and requalification.
• Manage audit observations and CAPAs; escalate when commitments are not met.
• Define QTAs and SLAs reflecting GxP responsibilities; collaborate with Procurement and Legal.
• Monitor supplier performance against QTAs/SLAs and drive corrective actions.
• Interpret regulatory expectations (EU GMP, 21 CFR Part 11, ICH) for outsourced activities.
• Represent supplier oversight during inspections and audits with accountability for GxP activities.
• Collaborate with cross-functional teams to integrate quality requirements into the full supplier lifecycle.
• Provide regular updates on supplier risk, audit status, and emerging risks.
• Be a process owner for supplier management procedures and mentor others.

Skills

Quality oversight

Risk assessment

GxP compliance

Vendor management

Audit management

Education

Bachelor degree in science/engineering/computer science or pharmaceutical-related field

Job description

Lilly seeks a CSV External Services Lead within GISQ to provide quality leadership for suppliers and third parties that develop or host GxP computerized systems. This individual-contributor role owns risk-based supplier assessments, manages observations and CAPAs, and ensures QTAs and SLAs reflect proper GxP responsibilities.

Travel is required to support supplier audits, and the position is based in Indianapolis, Indiana.