R&D Clinical Quality Assurance Associate Director
Core
Independent Clinical Quality Assurance Associate Director ensuring compliance with global regulations (GCP, PMDA, FDA, EMA) and patient safety through audits of clinical trial sites in Japan and APAC.
Role type
Senior IC Clinical Quality Assurance Associate Director (Japan/APAC focus)
Builds
Clinical trial quality assurance, audit reports, CAPA implementation, and risk-based audit plans for medical institutions and suppliers.
Domain
Pharmaceutical / Clinical Trials / Regulatory Compliance
Required skills
GCP Auditing, Investigative Auditing, Process Audits, Quality Risk Management, Vendor Audits, Clinical Reporting, Data Analysis, Validation Processes, Clinical Development Knowledge, Regulatory Knowledge (ICH-GCP, PMDA Act)
Preferred skills
Line Management, Global Team Experience, Training and Mentoring
Technologies
Audit Tools, Risk Assessment Frameworks, Regulatory Guidelines
Responsibilities
Conduct routine and directed audits at clinical trial sites in Japan and APAC; prepare and execute audits, write reports, and manage CAPA; analyze CtQ factors to create risk-based audit plans; evaluate compliance with ICH, PMDA, FDA, and EMA guidelines; escalate quality issues or deviations; support QA functional teams and QMU; develop and improve QA procedures and audit tools; standardize audit approaches; mentor junior QA members; manage staff productivity and engagement; act as the QA liaison for the Japan development department; collaborate with Country Offices and partners.
Seniority
Senior, hands-on IC with line management responsibilities
