Strategic CSV Quality Lead — Computer Systems

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

Benefits offered by this job

401(k) plan

Pension

Health insurance

Dental & Vision

Flexible spending accounts

Life insurance

Well-being program

Job summary

Lilly in Indianapolis, Indiana, is seeking a CSV Common Process Lead to provide SME guidance on GxP computerized system lifecycle processes within GISQ. You will own controlled procedures, drive regulatory alignment, and support inspections.

The role requires strong knowledge of GAMP 5, 21 CFR Part 11, and data integrity guidance, plus experience shaping CSV practices across multiple GxP domains. This is an individual contributor position based in Indianapolis with occasional travel.

Qualifications

• Bachelor's degree in science, engineering, computer science, or pharma-related field.
• 5+ years of demonstrated expertise in Computer System Validation and lifecycle management.
• 5+ years of expertise with GxP QMS processes (change control, deviation/CAPA, periodic review, retirement/decommissioning).
• Experience supporting or leading health authority inspections and audits.

Responsibilities

• Provide SME guidance for CSV lifecycle processes and change control.
• Own and maintain periodic review processes and ensure timely actions.
• Oversee retirement/decommissioning, data migration verification, and archival.
• Lead regulatory alignment for CSV processes and translate requirements into procedures.
• Represent CSV processes during inspections and audits and defend Lilly’s position.

Skills

CSV expertise

GxP QMS

Regulatory knowledge

Audits/inspections

Analytical skills

Communication skills

IT systems lifecycle

Education

Bachelor’s degree in a relevant field

Tools

GAMP 5

FDA 21 CFR Part 11

EU GMP Annex 11

Job description

Lilly in Indianapolis, Indiana, is seeking a CSV Common Process Lead to provide SME guidance on GxP computerized system lifecycle processes within GISQ. You will own controlled procedures, drive regulatory alignment, and support inspections.

The role requires strong knowledge of GAMP 5, 21 CFR Part 11, and data integrity guidance, plus experience shaping CSV practices across multiple GxP domains. This is an individual contributor position based in Indianapolis with occasional travel.