Associate Director, Quality Assurance

Quality Assurance Auditor

In this role you ensure safety, rights, and well-being of participants through independent QA for global clinical trials. You will perform GCP audits, generate reports, and drive CAPAs with cross-functional teams, including China operations. You'll apply risk-based auditing to protect data integrity and regulatory compliance. The role involves frequent travel in Asia-Pacific to execute audits and collaborate on quality improvements that support global studies.

Compensation / Benefits

• medical, dental, vision insurance
• retirement benefits including 401(k)
• paid holidays and vacation
• compassionate and sick days
• annual bonus and long-term incentive (where applicable)
• comprehensive benefits package

Responsibilities

• Plan and conduct QA audits across sites, offices, suppliers, and partners; produce audit reports and communicate findings to QA management and stakeholders; drive corrective and preventative actions to close observations
• Collaborate with teams in China to understand local regulations, GCP requirements, and responsibilities for global studies and new drug applications
• Apply risk-based auditing to identify Critical to Quality factors and potential risks
• Support GCP routine and directed audits and due diligence activities across sites and third-party collaborations
• Assist in identifying audit substrates in China for scheduling based on risk assessments and inputs from regional leads
• Travel up to 75% (primarily Asia-Pacific/China), with extended stays as needed
• Facilitate communication with stakeholders on quality events and audit findings; participate in Significant Quality Issues management and root-cause remediation

Key requirements

• Minimum 5 years of experience in a relevant field
• Bachelor's degree (BS/BA) or equivalent preferred
• Strong knowledge of GCP, regulatory compliance, and quality assurance processes
• Proven audit management and quality oversight capabilities
• Ability to travel internationally (China) and work with cross-cultural teams
• Experience with root-cause analysis and CAPA
• Excellent communication and stakeholder management skills

• Influence/Negotiation
• Ownership and Accountability
• Execution Excellence
• Audit Management
• Quality Assurance Processes
• Quality Auditing