Associate Director, Quality Assurance

Quality Assurance AuditorIn 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 / Benefitsmedical, dental, vision insuranceretirement benefits including 401(k)paid holidays and vacationcompassionate and sick daysannual bonus and long-term incentive (where applicable)comprehensive benefits packageResponsibilitiesPlan 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 observationsCollaborate with teams in China to understand local regulations, GCP requirements, and responsibilities for global studies and new drug applicationsApply risk-based auditing to identify Critical to Quality factors and potential risksSupport GCP routine and directed audits and due diligence activities across sites and third-party collaborationsAssist in identifying audit substrates in China for scheduling based on risk assessments and inputs from regional leadsTravel up to 75% (primarily Asia-Pacific/China), with extended stays as neededFacilitate communication with stakeholders on quality events and audit findings; participate in Significant Quality Issues management and root-cause remediationKey requirementsMinimum 5 years of experience in a relevant fieldBachelor's degree (BS/BA) or equivalent preferredStrong knowledge of GCP, regulatory compliance, and quality assurance processesProven audit management and quality oversight capabilitiesAbility to travel internationally (China) and work with cross-cultural teamsExperience with root-cause analysis and CAPAExcellent communication and stakeholder management skillsInfluence/NegotiationOwnership and AccountabilityExecution ExcellenceAudit ManagementQuality Assurance ProcessesQuality Auditing