Senior Manager, Global Development Quality Lead Japan

Key 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

Ideal Background

• 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
  
  

Benefits

Why Join?

• 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