Senior QA Auditor, GCP - Hybrid & Global Audits

Johnson & Johnson Co.

Titusville (NJ)

Hybrid

USD 94,000 - 152,000

Full time

4 days ago

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Benefits offered by this job

Hybrid work model

Competitive benefits

Job summary

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join the Quality Organization in Titusville, NJ. This hybrid role requires reporting to a listed site 3x per week, with audits across multiple sites including Raritan, NJ and Horsham, PA.

The QA team focuses on risk-based auditing to sustain compliance and drive reliability across Innovative Medicine. You will lead GCP audits, ensure adherence to SOPs, support regulatory inspections, and contribute to CAPA

Qualifications

Minimum 5 years of related auditing experience.
Knowledge of the drug development process and GCP guidelines (FDA/EU ICH).
Experience conducting Clinical Quality Assurance audits.
Understanding of clinical trial risk management.
Digital literacy and data analytics experience.
Willingness to travel up to 30%.

Responsibilities

Lead planning, conduct and reporting of GCP QA audits including routine and non-routine audits.
Ensure audit procedures and tools are applied consistently.
Analyze data to identify trends and CAPA outcomes.
Deliver timely CAPA reviews and actions.
Present information clearly in reports and trainings as needed.
Support regulatory inspections and inspection readiness.