Auditor

• Provide senior oversight and subject matter expertise to quality and compliance activities across clinical studies
• Support the Q&C Management team, Q&C staff, and project teams during all stages of a clinical study
• Serve as a subject matter expert for clinical project teams and represent Quality in project meetings
• Develop and implement complex quality and compliance concepts and techniques
• Support the Quality Management System including SOPs, training and CAPA
• Process and maintain documentation for controlled documents and maintain Q&C trackers, databases, metrics, and files
• Develop and administer training for employees and consultants and mentor Q&C staff
• Host client/sponsor audits and support regulatory inspections
• Coordinate and conduct assessments of potential and contracted vendors, including vendor audits
• Coordinate and conduct internal audits, investigator site audits, and trial master file audits
• Participate on computer systems validation projects and systems change control processes
• Monitor quality systems to provide feedback on compliance risks and identify opportunities for improvement
• Support proposals and bid defense meetings and perform additional tasks as required

Principal Quality Auditor, GCP

Principal Quality Auditor, GCP