Regeneron
Pharmaceutical
SeniorManager,GlobalDevelopmentQualityLeadJapan
Neural analysis suggests this role is
optimal for Senior candidates.
“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
Full Job Description
We are looking for a passionate and experienced Senior Manager to join our Global Development Quality & Regulatory Compliance team as the Global Development Quality Lead for Japan (GDQL-J). In this key role, you will lead quality and compliance initiatives within our local affiliate operations, supporting GCP, GVP, Medical, and Regulatory Affairs. This position offers an exciting opportunity to create strategic partnerships, drive proactive, risk-based quality activities, and foster a culture of continuous improvement. If you are ready to make a meaningful impact and grow with us, we encourage you to apply. **A Typical Day:** In this dynamic role, you will: * Lead GVP-compliant quality activities in collaboration with the business and GDQM team. * Provide expert guidance on inspection readiness, preparation, and management at the local affiliate level. * Partner with cross-functional teams to implement and sustain quality processes. * Conduct audits and support issue management related to GVP, GCP, Regulatory, and Medical Affairs. * Mentor, coach, and manage junior team members, fostering their professional growth. * Collaborate with local and global stakeholders to align quality strategies and operations. * Act as a subject matter expert in GCP and GVP, providing training and consultations. * Drive process improvement initiatives to enhance efficiency and compliance. **This Role May Be For You If:** You are someone who: * Thrives in a collaborative environment and builds strong stakeholder relationships. * Has a proactive approach to quality management and risk assessment. * Excels in managing complex quality issues and compliance activities. * Enjoys mentoring and developing team members to achieve their full potential. * Is detail-oriented and committed to maintaining the highest standards of quality. * Values innovation and continuous learning to stay ahead in the pharmaceutical industry. * Communicates effectively and influences peers and senior leaders alike.
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