Regeneron
Pharmaceutical
SeniorManager,GlobalDevelopmentQualityLeadJapan
“Senior Manager, Global Development Quality Lead Japan at Regeneron. Skills: Global Development Quality, GCP, GVP, Regulatory Compliance. Lead GVP-compliant quality activities. Provide expert guidance on inspection readiness”
Industry & Context.
Risk assessment; Issue management
What They're Looking For.
Must Have
Bachelor's degree, 8+ years relevant experience, Quality management background, Clinical development background, Advanced GCP knowledge, Advanced GVP knowledge, Regulatory inspection management experience, Native level Japanese proficiency, Business level English proficiency
Nice to Have
Expertise in risk-based quality management, Proficiency in Microsoft Office tools
What You'll Do.
Lead GVP-compliant quality activities
Provide expert guidance on inspection readiness
Prepare for inspections
Partner with cross-functional teams
Implement quality processes
Sustain quality processes
Support issue management
Mentor junior team members
Coach junior team members
Manage junior team members
Collaborate with stakeholders
Align quality strategies
Align quality operations
Act as subject matter expert
Provide consultations
Drive process improvement initiatives
How You'll Work.
Team & Collaboration
Cross-functional teams; Local stakeholders; Global stakeholders
Communication Scope
Influence senior leaders
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