R&D Clinical Quality Assurance Associate Director
Core
Lead clinical quality assurance audits and risk management for medical institutions across Japan and APAC to ensure global regulatory compliance and patient safety in clinical trials.
Role type
Associate Director, Clinical Quality Assurance (IC with line management)
Builds
Independent assurance of clinical trial processes, data integrity, and regulatory adherence for global pharma operations.
Domain
Pharmaceutical / Clinical Research / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP Auditing, Investigative Auditing, Process Audits, Vendor Audits, Quality Risk Management, Clinical Reporting, Data Analysis, Validation Processes, Clinical Quality Assurance, Accountability
Preferred skills
Line Management, Coaching and Development, Networking and Partnerships, Execution Excellence, Influence, Talent Growth, Diversity and Inclusion
Technologies
GCP, PMDA, ICH-GCP, FDA, EMA regulations
Responsibilities
Conduct routine and directed audits at medical institutions in Japan and APAC; Analyze CtQ factors to develop risk-based audit plans; Escalate quality issues or potential non-compliance to leadership; Mentor junior QA members and manage team performance; Collaborate with Country Offices and development teams on regulatory compliance; Contribute to global QA procedure standardization and tool development.
Seniority
Senior, hands-on IC with line management responsibilities
