CSV Lifecycle Quality Lead (GxP Systems)

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

Résumé du poste

Lilly is seeking a CSV Common Process Lead to provide SME guidance and quality oversight for GxP lifecycle processes, including change control, deviation/CAPA, periodic review, and retirement/decommissioning across GMP, GCP, GLP and GVP.

You will align CSV processes with Tech@Lilly, business partners and Quality, maintain inspection readiness, and drive improvements through procedural updates, regulatory intelligence, and training across the organization from manufacturing to QA.

Qualifications

• 5+ years of CSV and lifecycle management experience.
• Strong knowledge of GAMP 5, 21 CFR Part 11 and data integrity guidance.
• Experience supporting or leading health authority inspections.

Responsabilités

• CSV Lifecycle Oversight across GMP, GCP, GLP, and GVP.
• Lead change management, deviations, CAPA, and periodic review processes.
• Maintain inspection readiness and support training and documentation.
• Collaborate with Tech@Lilly, QA, and partners to improve processes.

Connaissances

GxP lifecycle knowledge

Quality oversight

Change management

Regulatory alignment

Cross-functional collaboration

Analytical problem solving

Formation

Bachelor's degree in science/engineering/CS/pharma

Outils

GAMP 5

21 CFR Part 11

Power BI

Veeva QMS

Description du poste

Lilly is seeking a CSV Common Process Lead to provide SME guidance and quality oversight for GxP lifecycle processes, including change control, deviation/CAPA, periodic review, and retirement/decommissioning across GMP, GCP, GLP and GVP.

You will align CSV processes with Tech@Lilly, business partners and Quality, maintain inspection readiness, and drive improvements through procedural updates, regulatory intelligence, and training across the organization from manufacturing to QA.