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 quality initiatives and inspection readiness.
Role type
Senior Manager, Global Development Quality Lead
Builds
Quality management system supporting GCP, GVP, Medical and Regulatory Affairs for the Japan affiliate
Domain
Healthcare / Pharmaceutical / Clinical Development
Required skills
GCP guidelines, GVP guidelines, quality management, compliance, audit management, inspection readiness, process improvement, issue resolution, training, line management, stakeholder engagement, project management
Preferred skills
risk-based quality management, digital literacy, behavioral adaptability
Technologies
Microsoft Office suite
Responsibilities
Lead quality and compliance activities for GCP, GVP, Medical and Regulatory Affairs; Build strategic partnerships and drive proactive, risk-based quality initiatives including audits; 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