Senior QA Clinical Auditor – Drive GCP Quality & Compliance

Johnson & Johnson Co.; Irvine (CA); Ibrido; USD 94.000 - 152.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization. This hybrid role reports to one of the listed sites: Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA and requires 3x/week on-site.

In R&D Quality, you’ll lead GCP QA audits, ensure adherence to regulatory requirements, drive CAPA execution, and support inspections. Domestic/international travel up to 30% may be required.

Competenze

• Minimum 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.
• Understanding of fundamentals of clinical trial risk management.
• Broad knowledge of management of standard operating procedures, good documentation practices, and records management.
• Digital literacy & Analytics - Experience using standard applications/systems & data analytics tools.
• Ability to plan and prioritize work in an efficient manner, and to work well under time constraints.
• Flexibility to respond to changing business needs.

Mansioni

• Independently leads planning, conduct and reporting of GCP QA audits and supports non-routine audits.
• Ensures audit procedures and tools are understood and applied.
• Analyzes data and identifies patterns and trends.
• Manages timely review and delivery of CAPAs from audits.
• Writes clear audit reports and presents information concisely.
• Provides GCP audit strategy support and risk-based auditing approaches.
• Supports regulatory inspections in various roles.
• Completes training requirements to ensure inspection readiness.
• May assist in training material preparation.
• Participates in projects or teams as assigned by supervisor.
• Meets priorities, checkpoints, and timelines for all work.

Conoscenze

Auditing

Clinical operations

GCP knowledge

Regulatory knowledge

Data analytics

Communication

Time management

Formazione

Bachelor's degree

Descrizione del lavoro

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization. This hybrid role reports to one of the listed sites: Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA and requires 3x/week on-site.

In R&D Quality, you’ll lead GCP QA audits, ensure adherence to regulatory requirements, drive CAPA execution, and support inspections. Domestic/international travel up to 30% may be required.