Compliance

• Lead and manage internal processes and systems, clinical and diagnostic quality audits, investigator sites and service provider audits, and gap assessments
• Identify areas of compliance vulnerability in clinical and CDx pipelines and develop/drive corrective and preventive action plans
• Provide routine clinical compliance support to clinical study and CDx project teams ensuring adherence to ICH E6 (GCP), relevant diagnostic regulations, and internal quality standards
• Support and lead risk assessment and mitigation strategies for clinical studies and CDx programs
• Lead and continuously refine the organization’s inspection readiness framework for clinical studies and companion diagnostic development across global and regional regulatory inspections (BIMO, pre-approval, GCP, CLIA, IVDR)
• Conduct inspection readiness training and coaching sessions
• Serve as primary point of contact for hosting inspections/audits, drafting and tracking responses to findings, driving resolution, and leading post-inspection lessons-learned initiatives
• Revise, develop, and maintain procedures within the Clinical Quality Management System leveraging lessons from inspections, audits, and emerging compliance trends
• Contribute to, implement, and continuously improve quality management policies and processes related to clinical studies, laboratory-developed tests, and companion diagnostic programs
• Own and maintain GCP audit program SOPs and templates
• Review and provide compliance advice on SOPs, processes, and protocols for clinical trial and companion diagnostic activities to ensure consistency with GCP, CLIA, FDA/IVDR, and other global diagnostic regulatory requirements
• Serve as subject matter expert and provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders
• Promote a culture of quality and clinical compliance and collaborate with cross-functional teams and senior leaders to establish inspection norms and foster continuous improvement

Associate Director, Clinical Compliance

Business Control Manager – Technology Risk & Regulatory Engagement Lead

Business Control Manager – GT Risk & Regulatory Engagement Lead

Business Control Manager – Technology Risk & Regulatory Lead

Quality Specialist – Customer Compliance

Senior Director, Compliance & Ethics – PRISM, Multi-Specialty MSOs