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About the Role
This senior, high-visibility quality leadership role within the Japan affiliate offers broad exposure across GCP, GVP, Medical, and Regulatory Affairs. You will play a key role in strengthening quality systems, inspection readiness, and compliance, while having the opportunity to influence strategic quality initiatives and process improvements.
Responsibilities
- Lead quality and compliance activities across GCP, GVP, Medical Affairs, and Regulatory Affairs for the Japan affiliate.
- Provide strategic quality guidance and drive risk-based quality initiatives, including audits.
- Lead and support inspection readiness and preparation for local operations.
- Identify and drive process improvements aligned with quality objectives.
- Manage quality issues and ensure appropriate escalation of significant non-compliance.
- Provide expert guidance and training on international regulations and company quality standards.
- Partner with local and global stakeholders to strengthen the quality management system.
- Coach and mentor junior team members and/or take ownership of key quality processes.
Requirements
- Bachelor's degree or equivalent experience.
- 8+ years of relevant experience in the pharmaceutical or healthcare industry.
- Strong knowledge and practical application of GCP and/or GVP.
- Background in quality/compliance or clinical development, with solid GCP/GVP expertise.
- Experience managing complex quality and compliance issues.
- Experience in training, supervision, line management, or staff development.
- Strong project management, planning, and prioritization skills.
- Experience with risk-based quality management and process improvement.
- Strong communication and stakeholder management skills, including the ability to influence senior stakeholders.
- Strong analytical, problem-solving, and collaborative skills.
Skills
- GCP
- GVP
- Quality Management
- Compliance
- Risk Management
- Process Improvement
- Project Management
- Stakeholder Management
- Communication
- Analytical Skills
- Problem-Solving
- Collaboration
Location
- Tokyo
Work Type
- Hybrid
Experience Level
- 8+ years
Education Level
- Bachelor's degree or equivalent
Benefits
- Join a fast-growing global biopharmaceutical company with an innovative pipeline.
- Take on a senior, high-visibility quality leadership role within the Japan affiliate.
- Gain broad exposure across GCP, GVP, Medical, and Regulatory Affairs.
- Work closely with global and Japan stakeholders in an international environment.
- Play a key role in strengthening quality systems, inspection readiness, and compliance.
- Opportunity to influence strategic quality initiatives and process improvements.
- Hybrid working model in Tokyo.
- Opportunity to develop and mentor others while continuing to grow as a quality leader.
About the Company
- Fast-growing global biopharmaceutical company with an innovative pipeline.