CSV Lifecycle Quality Lead (Computer Systems)

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

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off & leave benefits

Well-being benefits

Job summary

Lilly in Indianapolis is seeking a CSV Common Process Lead to drive the lifecycle management of validated computerized systems across GMP, GCP, GLP, and GVP. You will own cross-functional processes, provide expert guidance on regulatory expectations, and lead inspections readiness.

The role requires deep expertise in CSV, QMS processes, and strong collaboration with Tech@Lilly, Quality, and business partners to maintain compliance and continuous improvement.

Qualifications

• Bachelor degree in a science, engineering, computer science or pharmaceutical-related field; or equivalent experience.
• 5+ years in Computer System Validation and lifecycle management with GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and data integrity guidance.
• 5+ years with GxP QMS processes (change control, deviation/CAPA, periodic review, retirement/decommissioning).
• Experience supporting or leading health authority inspections and audits; ability to influence at executive levels.
• Proficiency with IT systems development life cycle and risk-based validation approaches.

Responsibilities

• Provide SME guidance for CSV lifecycle processes and ensure continued validated state across GMP, GCP, GLP, and GVP.
• Own or act as SME for CSV common processes and ensure coherent, fit-for-purpose process architecture.
• Lead regulatory intelligence and translate requirements into procedural updates and implementation plans.
• Oversee lifecycle process execution, review health trends, and drive CAPA when systemic issues are detected.
• Represent CSV processes during inspections and audits, defending Lilly's position on CSV practices.
• Coordinate alignment between Tech@Lilly, business partners, Quality, and supporting functions.

Skills

Analytical thinking

Problem solving

Communication skills

Regulatory understanding

Stakeholder influence

Education

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

Tools

Power BI

Job description

Lilly in Indianapolis is seeking a CSV Common Process Lead to drive the lifecycle management of validated computerized systems across GMP, GCP, GLP, and GVP. You will own cross-functional processes, provide expert guidance on regulatory expectations, and lead inspections readiness.

The role requires deep expertise in CSV, QMS processes, and strong collaboration with Tech@Lilly, Quality, and business partners to maintain compliance and continuous improvement.