Associate Director, Clinical Quality Assurance

Role Overview

Reporting to the Director of Clinical Quality Assurance, the Associate Director of Clinical Quality Assurance (CQA) - Japan & APAC serves as a CQA lead representative on the development team assuring quality and regulatory compliance related to GCPs and other related activities performed by Medical/Clinical Departments in Japan and Asia-Pacific (APAC) region.

What You Will Do

Perform audits of investigator sites, vendors, and internal systems/processes. Support the evaluation and acceptability of vendors for potential use and provide direction, guidance and strategy for company Quality and Compliance.

Why It Might Be a Fit

Must demonstrate practical working knowledge of GCP regulations. Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.

Requirements

• Minimum BS degree in Biology or Chemistry or related life sciences discipline
• 7-10 years of experience
• Advanced degree (MS, PhD, MBA) preferred
• Experience in effectively managing regulatory agency inspections
• GCP audit experience
• Ability to conduct external audits of investigator sites, CROs, supporting laboratories, and monitoring organizations

Benefits

• Flexible work hours
• Comprehensive vacation system
• Competitive compensation package
• Retirement plan
• Stock option plan
• Employee stock purchase plan (ESPP)
• Professional development support
• Digital assistant for learning and resource access
• Global recognition program
• Hybrid work environment with advanced technology