Clinical Quality Specialist

Clinical Quality Specialist Overview

• The Clinical Quality Specialist will support compliance for clinical studies, vendor management, and inspection readiness under the direction of the Clinical Quality Assurance team.
• Ensure adherence to global regulations, ICH guidelines, and GxP standards through meticulous quality operations management.
• Collaborate with internal and external stakeholders to schedule audits and manage quality investigations effectively.
• Generate and analyze metrics to enhance Clinical Quality Operations and support continuous improvement initiatives.
• Participate in regulatory inspections, inspection readiness activities, and forums to uphold compliance standards.
• Provide training management and onboarding support for new employees to strengthen the Clinical Quality team.
• Maintain and manage the Clinical Quality Vendor Management database to ensure accurate and efficient operations.

Clinical Quality Specialist Key Responsibilities & Duties

• Process audit reports, change controls, deviations, and audit plans to ensure compliance with approved procedures.
• Coordinate investigations and escalations of issues identified during Clinical Quality Operations, ensuring timely resolutions.
• Schedule audits with internal and external stakeholders, maintaining clear communication and documentation.
• Collect and generate metrics to monitor and improve Clinical Quality Operations performance.
• Participate in meetings and workshops with stakeholders to gather requirements for process improvements.
• Support regulatory inspection readiness activities and contribute to compliance initiatives.
• Provide training and onboarding support to enhance team capabilities and knowledge.
• Manage and maintain the Clinical Quality Vendor Management database to ensure operational efficiency.

Clinical Quality Specialist Job Requirements

• Bachelor’s degree in a relevant technical, scientific, or quality discipline is required.
• Minimum of 3 years of experience in pharma, CRO, or clinical healthcare settings; 5 years preferred.
• Proficiency in MS Word, Excel, and Quality System processes; experience with Veeva, TrackWise, and ComplianceWire is advantageous.
• Strong understanding of US FDA and European regulatory requirements, ICH guidelines, and GxP standards.
• Experience in vendor management and audit scheduling is highly desirable.
• Ability to generate and analyze metrics to support quality operations improvements.
• Excellent communication and collaboration skills to work effectively with stakeholders.
• Familiarity with Co-Pilot software is a plus.