Associate Director, Clinical Quality Assurance

Conduct QA reviews of key clinical trial documentation including protocols, investigator brochures, and informed consent forms. Drive assessment and investigation of quality issues through root cause analysis, remediation, and timely closure. Facilitate Serious Breach and Urgent Safety Measure assessments and coordinate GCP/GVP vendor audits with risk-based site selection. Oversee quality with functional lines and vendors by facilitating Quality Oversight Committee meetings and providing input to Quality Systems reviews. Lead pre-approval and routine regulatory inspection readiness activities, including risk analysis, strategy development, and support during Health Authority inspections. Provide guidance, training, and input on compliance issues while supporting GCP SOP development and implementation.