JOB DESCRIPTION: We are currently seeking a highly qualified Clinical Quality Manager to join our Regulatory Affairs department in Richmond, VA. The successful candidate will be responsible for creating and enhancing clinical quality requirements and standards for our network of Contract Research Organizations (CROs) and will work with multiple business partners to prepare and assure FDA inspection readiness. In addition, this role will conduct quality system gap assessments to evaluate clinical operations quality systems for conformance to requirements and then assist in the development and tracking of gap remediation plans. Specific accountabilities include: Leading Clinical Quality Management Reviews (summarizing quality audits, deviations and CAPA trends f
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