Senior Manager, Global Development Quality Lead Japan
Core
Lead quality and compliance activities for GCP, GVP, Medical, and Regulatory Affairs at the Japan affiliate, driving risk-based initiatives and inspection readiness.
Role type
Senior Manager, Global Development Quality Lead
Builds
Quality management system supporting GCP, GVP, Medical, and Regulatory Affairs operations
Domain
Healthcare / Pharmaceutical / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP guidelines, GVP guidelines, quality management system, audit management, inspection readiness, process improvement, issue resolution, regulatory compliance, line management, staff development, project management, risk-based quality management
Preferred skills
Advanced digital literacy, stakeholder engagement, critical thinking, collaborative problem solving
Responsibilities
Lead quality and compliance activities for GCP, GVP, Medical and Regulatory Affairs; Build strategic partnerships and drive proactive, risk-based quality initiatives; Optimize inspection readiness and support inspection preparation; Contribute to process improvement initiatives; Manage issue resolution and escalate serious non-compliances; Provide expert guidance, training, and support on international regulations; Line manage, coach, and mentor junior team members
Seniority
Senior Manager, hands-on leadership with team management
