Clinical Quality Specialist

Hybrid Details: 3-5 days/week onsite Duration Details: 6 months to start Job Description� The Clinical Quality Specialist, under the direction of the CQA management team, will be responsible to support Clinical Quality and their operations in ensuring compliance of client clinical studies, vendor management, and inspection readiness according to approved procedures, global regulations and ICH, GxP requirements. Position Details Support the processing of audit reports, change controls, deviation, and audit plansSupport CQA team in the coordination, investigation, escalation, and resolution of issues identified during Clinical Quality OperationsSupport scheduling of audits with internal and external stakeholdersCollect and generate metrics for Clinical Quality Operations. Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEsParticipate in CQA meetings and the additional forums including but not limited to Inspection Readiness and Regulatory InspectionsAssist Clinical Quality in supporting internal and external stakeholders in the processing of deviations, Quality Investigations, and auditsFollow-up on requests, issues, and projects and report statuses to manager and CQA teamSupport the management and maintenance of the Clinical Quality Vendor Management database. Provide CQA support through training management and onboarding of new employees. Academic/Technical Qualifications Bachelor s degree or higher in relevant computer, technical, quality, scientific discipline, preferably multi-disciplinary with a strong technical and quality backgroundMinimum of 2-5 years of experience in commercial pharma, CRO, clinical pharma, or healthcare facilityProficient in MS Word, Excel, and Quality System processes. Experience with Veeva, TrackWise, and ComplianceWire is a plus. Understanding and working knowledge of US FDA and European regulatory requirements. Knowledge of Regulatory Compliance, ICH Guidelines, GxP standards