CSV Quality Process Lead – Lifecycle Compliance SME

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 117 000 - 172 000; Plein temps

Résumé du poste

Eli Lilly and Company, headquartered in Indianapolis, Indiana, is seeking an experienced CSV Common Process Lead to oversee the lifecycle of validated computerized systems. You will ensure regulatory alignment across GMP, GCP, GLP, and GxP disciplines, and provide SME-level guidance on change control, deviation, CAPA, and periodic reviews.

You will represent quality during inspections, coordinate with Tech@Lilly and business partners, and lead efforts to improve CSV processes and training.

Qualifications

• Bachelor degree in science, engineering, or related field.
• 5+ years in Computer System Validation and lifecycle management.
• 4+ years with GxP QMS processes (change control, deviation, CAPA).
• Experience supporting health authority inspections and audits.
• Strong communication and ability to influence at Executive level.
• Proficiency with IT systems development life cycle and risk-based validation.
• Ability to oversee end-to-end CSV across GxP domains.

Responsabilités

• Provide SME guidance for CSV lifecycle processes (change control, validation, and retirement).
• Oversee deviation and CAPA management with timely closure and data quality.
• Own periodic review processes for continued validated state.
• Guide retirement/decommissioning including data migration verification.
• Draft and maintain procedures and training impact for changes.
• Support health authority inspections and company positioning on CSV practices.

Connaissances

CSV Validation & Lifecycle

GxP Knowledge

Executive Communication

Analytical Thinking

Formation

Bachelor degree in science, engineering, or related field

Outils

Veeva QMS

Description du poste

Eli Lilly and Company, headquartered in Indianapolis, Indiana, is seeking an experienced CSV Common Process Lead to oversee the lifecycle of validated computerized systems. You will ensure regulatory alignment across GMP, GCP, GLP, and GxP disciplines, and provide SME-level guidance on change control, deviation, CAPA, and periodic reviews.

You will represent quality during inspections, coordinate with Tech@Lilly and business partners, and lead efforts to improve CSV processes and training.