Clinical Quality Specialist in Weston, Massachusetts

Clinical Quality Specialist

6-month Contract Hybrid in Waltham, MA

Requirements

• Support Clinical Quality operations to ensure compliance of clinical studies, vendor management, and inspection readiness in accordance with approved procedures, global regulations, ICH guidelines, and GxP requirements.
• Support the processing of audit reports, change controls, deviations, and audit plans.
• Support the Clinical Quality team in the coordination, investigation, escalation, and resolution of issues identified during Clinical Quality operations.
• Support the scheduling of audits with internal and external stakeholders.
• Collect and generate metrics for Clinical Quality operations.
• Assist in gathering requirements for process improvements and ongoing maintenance by participating in meetings and workshops with Site Process Owners and business SMEs.
• Participate in Clinical Quality meetings and additional forums, including Inspection Readiness and Regulatory Inspections.
• Support internal and external stakeholders in the processing of deviations, quality investigations, and audits.
• Follow up on requests, issues, and projects, and report status updates to management and the Clinical Quality team.
• Support the management and maintenance of the Clinical Quality Vendor Management database.
• Provide Clinical Quality support through training management and onboarding of new employees.

Qualifications

• Bachelor's degree or higher in a relevant computer, technical, quality, or scientific discipline; multidisciplinary background with strong technical and quality experience preferred.
• 2-5 years of experience in commercial pharmaceutical, CRO, clinical pharmaceutical, or healthcare environments.
• Proficiency with Microsoft Word, Excel, and Quality System processes.
• Experience with Veeva, Track Wise, and Compliance Wire is a plus.
• Understanding and working knowledge of U.S. FDA and European regulatory requirements.
• Knowledge of regulatory compliance, ICH guidelines, and GxP standards.