Senior QA Auditor, Clinical Compliance & GCP

Johnson & Johnson Co.; Raritan (NJ); On-site; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation 120 hours

Sick time

Holiday pay

Parental Leave

Bereavement Leave

Job summary

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join the Quality Organization. The role supports multiple U.S. sites in a hybrid structure and reports to one listed site at least 3 days per week.

The successful candidate will lead GCP QA audits, ensure adherence to regulatory requirements, and drive CAPA management across the organization. Strong data analytics and communication skills are essential.

Qualifications

• Minimum 5 years of experience in auditing or QA for clinical programs.
• Deep knowledge of drug development and regulatory guidelines.
• Experience conducting Clinical Quality Assurance audits.
• Understanding of clinical trial risk management.
• Familiarity with SOPs, GMP/GCP practices.
• Strong documentation and reporting skills.
• Proficient in data analytics and digital tools.
• Excellent planning and prioritization under deadlines.
• Willingness to travel up to 30%.

Responsibilities

• Lead planning, conduct, and reporting of GCP QA audits.
• Ensure audit tools and plans are followed.
• Analyze data to identify trends.
• Review and close CAPAs arising from audits.
• Prepare clear, concise audit reports.
• Support regulatory inspections.
• Complete required training to ensure inspection readiness.
• Contribute to training materials as needed.
• Participate in projects and teams as assigned.
• Meet priorities and timelines for all work.

Skills

GCP Auditing

Clinical operations

Regulatory knowledge

QA risk management

Data analytics

Documentation practices

Education

Bachelor's degree

Job description

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join the Quality Organization. The role supports multiple U.S. sites in a hybrid structure and reports to one listed site at least 3 days per week.

The successful candidate will lead GCP QA audits, ensure adherence to regulatory requirements, and drive CAPA management across the organization. Strong data analytics and communication skills are essential.