Senior Specialist, Quality Assurance Clinical Auditor

Johnson & Johnson seeks a Senior Specialist, Quality Assurance Clinical Auditor to lead GCP audits and quality assessments across clinical sites, trial programs, and service providers. The role involves independent audit planning, regulatory compliance monitoring, and corrective action oversight within R&D Quality, based at one of six U.S. locations on a hybrid schedule.

Responsibilities

• Lead planning, conduct, and reporting of GCP routine and non-routine audits across investigator sites and trial programs
• Analyze data patterns, identify trends, and ensure timely corrective action plan review and delivery
• Ensure audit procedures, tools, and plans are properly understood and applied during audit activities
• Support regulatory inspections and maintain inspection readiness through assigned training
• Present audit findings logically in written reports and verbal communications

Requirements

• Bachelor's degree minimum
• 5+ years auditing, clinical operations, or related experience
• Knowledge of drug development, regulations, R&D practices, and GCP
• Experience conducting clinical quality assurance audits of sites or studies
• Understanding of clinical trial risk management fundamentals
• Digital literacy and data analytics tool proficiency
• Strong planning, prioritization, and time management capabilities