Data Integrity Lead/QA-IT
Core
Lead Data Integrity governance, strategy, and compliance for a pharmaceutical manufacturing site, ensuring GxP computerized systems meet regulatory standards.
Role type
Senior Data Integrity Lead (QA-IT)
Builds
Data Integrity framework, compliance strategies, and a culture of quality within pharmaceutical manufacturing.
Domain
Pharmaceutical manufacturing / Quality Assurance / Computerized Systems Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Data Integrity governance, GxP compliance, QA oversight of computerized systems, risk-based validation, regulatory inspection readiness, CAPA management, stakeholder influence, strategic roadmap development
Preferred skills
QA-IT professional experience, GxP systems implementation (MES/LIMS/CDS/eQMS), digital transformation programs
Technologies
GxP systems, MES, LIMS, CDS, eQMS, automation systems
Responsibilities
Define and drive the site's Data Integrity plan and roadmap; Provide QA oversight of GxP computerized systems lifecycle; Lead investigations and CAPA for compliance gaps; Develop and deliver Data Integrity training programs
Seniority
Senior, hands-on IC with leadership scope
