Site DI & E-Compliance Lead
Core
Lead the implementation of Data Integrity strategy and E-Compliance for a manufacturing site, ensuring regulatory compliance for documentation and electronic systems supporting GMP processes.
Role type
Site Data Integrity & E-Compliance Lead
Builds
Compliant GMP documentation and electronic systems
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data Integrity, Quality Management Systems (QMS), GxP compliance, CAPA management, Internal Business Monitoring, Root Cause Analysis, Cross-functional coordination, Training Matrix development, Inspection readiness
Preferred skills
Multisite community of practice leadership, Veeva system proficiency, GMP policy enforcement
Technologies
Veeva
Responsibilities
Develop indicators to monitor data integrity process performance; Coordinate cross-functional assessment of GxP systems; Lead internal site network of DI champions; Perform routine inspection readiness Gemba audits; Lead Management Monitoring and Internal Business Monitoring; Assist as Admin role on assigned QC Equipment/Systems and validated GxP spreadsheets.
Seniority
Mid-level, hands-on IC
