【astrazeneca】【r&d】associate Director, Clinical Quality Management, R&d Development Operations Division
AstraZeneca
Osaka, Japan
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Clinical quality management system
Gcp activities
Local and international regulations
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The role of Associate Director, Clinical Quality Management at AstraZeneca in Osaka or Tokyo requires an experienced leader to oversee quality activities within the Clinical Quality Management System. The ideal candidate will possess significant experience in the pharmaceutical industry, particularly in clinical development, and will have strong leadership and communication skills.
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Job Summary
Associate Director Clinical Quality Management leads the planning and implementation of all quality activities adapting to changes in the environment through relevant Clinical Quality Management System.
ADCQM is responsible for proactive contribution to Japan Development Operations (J-DO) and global member in Quality Management or Quality Assurance to develop capabilities to achieve high level of performance and productivity.
Ensures Always Inspection Ready (AIR) including PMDA, EMA, FDA and other Health Authority inspection ready in Japan and guides study teams to adopt clinical study audit and inspection-ready standards.
Matching Summary
Match Score: 75
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The role of Associate Director, Clinical Quality Management at AstraZeneca in Osaka or Tokyo requires an experienced leader to oversee quality activities within the Clinical Quality Management System. The ideal candidate will possess significant experience in the pharmaceutical industry, particularly in clinical development, and will have strong leadership and communication skills.
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Skills & Requirements
Must-have
Clinical Quality Management System
GCP activities
local and international regulations
quality risk and issue management
compliance risk and issue management
Procedural Document simplification
Nice-to-have
Process Management
Business Process Management
professional excellence
customer and integrity focus
Key Requirements
At least 5 years' experience in pharmaceutical industry
At least 3 years' experience in Clinical Development/Assurance/Advice
Bachelor’s degree in biological science or clinical research discipline