IT Quality Manager
Core
Ensures IT projects, systems, and services meet internal/external regulatory requirements and governs quality/compliance for AI-enabled manufacturing systems.
Role type
IT Quality Manager (Regulatory & Compliance)
Builds
Quality governance frameworks, validation plans, and compliance strategies for IT and 3rd party suppliers.
Domain
Pharmaceutical industry IT / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
GxP validation, regulatory impact determination (RID), CAPA/Deviation management, supplier assessment, quality plan authoring, GAMP, ISO 9000/27002, CMMI, ITIL, SOx
Preferred skills
Project/service management, infrastructure/application technical concepts, ISPE PCC CPIP, ISACA CISM
Technologies
GAMP, ISO 9000, ISO 27002, CMMI, ITIL, S404
Responsibilities
Apply Quality Management processes to assure regulatory compliance; govern quality for AI-enabled manufacturing systems; act on risks to raise compliance levels; develop training campaigns; contribute to IT policy improvement; review system lifecycle deliverables (RID, protocols, Test Closure Memo); approve Exceptions/CAPA/Deviations; define Quality Plans with Project Managers; lead supplier assessments; act as QM point of contact for inspections; monitor quality data accuracy.
Seniority
Mid-level, hands-on IC
