Digital Quality & GxP Manager
Core
Manage compliance risk and provide practical guidance on GxP quality across the software product lifecycle, including internal and external software products, systems, and AI products.
Role type
Senior IC Digital Quality & GxP Manager
Builds
Digital/software components of quality management systems, including AI quality management systems
Domain
Healthcare / Clinical Research / Software Validation
Deliverable
production ML models
Required skills
GxP compliance, Computer Systems Validation (CSV), SaaS application development, Agile product development, Vendor compliance review, Regulatory audit preparation, Quality management system development
Preferred skills
Project management, GxP quality certifications, Quality systems management certifications
Technologies
SaaS platforms, AI systems, Quality Management Systems (QMS)
Responsibilities
Review and approve validation of software and AI products; Prepare for and support external regulatory audits; Lead internal or vendor audits; Proactively monitor systems and processes for compliance; Review key vendors for compliance; Train and educate internal stakeholders on quality processes
Seniority
Senior, hands-on IC