Janice Hall L.

Senior Quality Assurance Auditor i @Rho

Durham, NC, US

Plan, coordinate, and host sponsor audits of Rho, including the oversight of Rho’s responses to audit findings from initial response through delivery of promised processes changes. Assist the organization in preparation for the coordination, hosting, conduct, documentation and follow-up of regulatory inspections. Evaluate internal compliance with company procedures, policies, programs, initiatives, GCP, and applicable regulations. Lead and/or assist audit activities including clinical site audits, key document audits, and software and system validation documentation audits. Conduct audits of clinical trial vendors providing services such as central imaging, central laboratory services, ECG, IP management and distribution, IRT, ePRO/eCOA, and EDC systems. Assist in the creation, review, revision and management of procedural documents. Clearly communicate and report (verbally and in writing) audit outcomes and escalate significant compliance concerns to project teams, QA and Rho management, and sponsor contacts. Maintain significant knowledge in regulatory requirements and ICH GCP principles. Provide regulatory compliance guidance and quality improvement consult to internal and external customers. Report, manage and follow deviations, complaints, issues, non-conformances and their related CAPAs. Assist in the management of contract auditors. Support business proposal preparation and defense. Prepare training materials and conduct training related to relevant QA topics.

Kean University

Bachelor of Science (B.S.), Management Science

American InterContinental University

Master of Business Administration (M.B.A.), Marketing