Regeneron

Pharmaceutical

SeniorManager,GlobalDevelopmentQualityLeadJapan

$15000–22000k ~AI est. Tokyo, Japan FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Pharmaceutical
Problems you'll solve

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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