Senior QA Clinical Auditor - Hybrid (GCP)

Johnson & Johnson Co.; Irvine (CA); Hybrid; USD 94,000 - 152,000; Full time

Benefits offered by this job

Vacation & Holidays

Parental Leave

401(k) Plan

Job summary

Johnson & Johnson is hiring for a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization across Titusville, Raritan, Horsham, Spring House, Irvine or La Jolla. This is a hybrid role, requiring on-site presence 3 days per week at a listed site.

You will lead planning and execution of GCP QA audits, support regulatory inspections, and drive CAPA actions, with emphasis on risk-based auditing and compliance across programs.

Qualifications

• 5+ years of related work experience in auditing, clinical operations, or other key related area.
• Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology.
• Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, EU CTR, ICH E6 R2).
• Experience conducting Clinical Quality Assurance audits or assessments of clinical investigator sites, studies, or systems

Responsibilities

• Independently leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits.
• Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
• Analyzes, interprets data and identifies patterns and trends in data sets.
• Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.
• Presents information clearly in reports and verbally, and supports QA risk-based auditing approaches.

Skills

GCP knowledge

Audit planning

Regulatory compliance

Data analytics

Education

Bachelor's degree

Tools

Audit tools

Job description

Johnson & Johnson is hiring for a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization across Titusville, Raritan, Horsham, Spring House, Irvine or La Jolla. This is a hybrid role, requiring on-site presence 3 days per week at a listed site.

You will lead planning and execution of GCP QA audits, support regulatory inspections, and drive CAPA actions, with emphasis on risk-based auditing and compliance across programs.