GxP CSV Supplier Quality Oversight Lead

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

Job summary

Lilly is seeking a CSV External Services Lead to head quality oversight of suppliers and third parties who develop, host, or validate GxP computerized systems. You will lead risk-based supplier quality management and ensure QTAs and SLAs meet regulatory expectations, with cross-functional collaboration across Procurement, Legal, and Cyber Security.

This individual contributor role requires GxP experience, strong communication, and the ability to influence without direct authority.

Qualifications

• Bachelor or higher in science, engineering, CS/IT, or pharma field.
• Experience with GxP, 21 CFR Part 11, EU GMP Annex 11 is preferred.
• Excellent communication and stakeholder management.
• Ability to influence cross-functionally without direct authority.

Responsibilities

• Lead supplier quality oversight for CSV/IT services and SLAs.
• Own QA requirements in QTAs and ensure alignment with regulatory expectations.
• Represent supplier oversight during inspections and audits.
• Coordinate with Procurement, Legal, Cyber Security on risk and vendor management.

Skills

Strong communication

Influence without authority

Interpersonal skills

Negotiation

Education

Bachelor's degree in science/engineering/computer science or pharma-related field

Job description

Lilly is seeking a CSV External Services Lead to head quality oversight of suppliers and third parties who develop, host, or validate GxP computerized systems. You will lead risk-based supplier quality management and ensure QTAs and SLAs meet regulatory expectations, with cross-functional collaboration across Procurement, Legal, and Cyber Security.

This individual contributor role requires GxP experience, strong communication, and the ability to influence without direct authority.