R&D Clinical Quality Assurance Associate Director

Our Quality Assurance (QA) function is an independent organization that focuses on quality at all critical stages of the product development life cycle. The Clinical Quality (CQ) function ensures clinical trials are conducted in compliance with applicable global regulatory requirements.

Requirements

• Conducts GCP routine audits and directed audits at investigator sites in Japan and APAC
• Prepares for, conducts, and reports on audits; prepares and submits audit reports
• Ensures that CAPA measures are properly implemented and issues are closed
• Analyzes and utilizes CtQ factors to identify potential risks and develops and implements risk-based audit plans
• Evaluates the compliance of investigator sites, Suppliers, Clinical Development Department, and Clinical Trial Reports and applications with ICH, applicable regulatory guidelines, company policies, procedures, and industry standards

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance