【astrazeneca】【r&d】associate Director, Clinical Quality Management, R&d Development Operations Division
AstraZeneca
Osaka, Japan
5+ years pharmaceutical industry experience
3+ years clinical development or assurance
Gcp and drug development process knowledge
The Associate Director leads the planning and implementation of all quality activities within the Japan Development Operations division through a robust Clinical Quality Management System
Job Summary
The Associate Director leads the planning and implementation of all quality activities within the Japan Development Operations division through a robust Clinical Quality Management System.
This role ensures Always Inspection Ready status for PMDA, EMA, FDA, and other Health Authority inspections by guiding study teams to adopt audit-ready standards.
Candidates must demonstrate courageous leadership to challenge the status quo while fostering a culture of empowerment and high performance across global and local teams.
Matching Summary
The Associate Director leads the planning and implementation of all quality activities within the Japan Development Operations division through a robust Clinical Quality Management System.
Skills & Requirements
Must-have
5+ years pharmaceutical industry experience
3+ years clinical development or assurance
GCP and drug development process knowledge
Local and international regulation proficiency
Native Japanese and Business English fluency
Bachelor's degree in biological science
Nice-to-have
Process management and procedural document development
Business Process Management (BPM) experience
MBA or Project Management Professional certification
Cross-functional change program leadership
High professional achievement background
Key Requirements
Minimum 5 years pharmaceutical industry experience
At least 3 years in Clinical Development/Assurance
Native level Japanese language skills required
Business English proficiency required
Bachelor's degree in biological science or related field