Quality Specialist

Overview Support Clinical Quality operations ensuring compliance with global regulations, ICH guidelines, and GxP standards. Coordinate vendor management activities and maintain the Clinical Quality Vendor Management database. Assist in audit scheduling, processing audit reports, and managing deviations and quality investigations. Participate in Clinical Quality Assurance (CQA) meetings and inspection readiness forums. Generate metrics and reports for Clinical Quality Operations to support decision‑making. Provide training management and onboarding support for new employees in Clinical Quality. Collaborate with stakeholders to gather requirements for process improvements and system maintenance. Key Responsibilities & Duties Coordinate and schedule audits with internal and external stakeholders to ensure compliance. Investigate and resolve issues identified during Clinical Quality Operations. Support the management of change controls and deviation processes. Assist in inspection readiness activities and regulatory inspections. Maintain and update the Clinical Quality Vendor Management database. Provide training and onboarding support to new employees in the Clinical Quality team. Generate and analyze metrics to support Clinical Quality operations and reporting. Collaborate with Site Process Owners and SMEs to gather requirements for system improvements. Job Requirements Bachelor’s degree in a relevant technical, quality, or scientific discipline. Minimum of 3 years of experience in commercial pharma, CRO, or clinical healthcare. Proficiency in MS Word, Excel, and Quality System processes; experience with Veeva, TrackWise, and ComplianceWire preferred. Strong understanding of US FDA and European regulatory requirements. Knowledge of Regulatory Compliance, ICH Guidelines, and GxP standards. Ability to collaborate effectively with internal and external stakeholders. Excellent organizational and communication skills to manage multiple projects. #J-18808-Ljbffr