Senior QA Clinical Auditor - Hybrid, Risk-Based Compliance

Johnson & Johnson Co.; San Diego (CA); Hybride; USD 94 000 - 152 000; Plein temps

Avantages offerts par ce poste

Vacation time

Sick leave

Holiday pay

Parental Leave

Volunteer Leave

Résumé du poste

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization across multiple sites in the U.S. Hybrid role reporting to a site 3x/week.

This role emphasizes GCP QA audits, risk-based approaches, regulatory readiness, and collaboration with R&D. Travel up to 30% may be required; a Bachelor's degree and 5+ years in auditing are expected.

Qualifications

• Minimum 5 years auditing, clinical operations, or related area.
• Knowledge of drug development process and regulatory guidelines.
• Experience conducting Clinical Quality Assurance audits of sites or studies.
• Understanding of clinical trial risk management fundamentals.
• Familiarity with SOPs, documentation practices and records management.
• Digital literacy and analytics with standard data tools.
• Ability to plan, prioritize work under time constraints.
• Willingness to travel up to 30% (domestic/international).

Responsabilités

• Lead planning, conduct and reporting of GCP QA routine audits and support non-routine audits.
• Ensure audit procedures, tools and plans are applied correctly.
• Analyze data to identify patterns and trends.
• Deliver CAPAs and actions from audits in a timely manner.
• Present information clearly in reports and verbally.
• Provide QA strategy support for risk-based audits and audit plans.
• Support regulatory inspections as needed.
• Complete training requirements for inspection readiness.

Connaissances

GCP knowledge

Clinical QA audits

Data analytics

Regulatory knowledge

Trial risk management

Time management

Adaptability

Formation

Bachelor's degree

Description du poste

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization across multiple sites in the U.S. Hybrid role reporting to a site 3x/week.

This role emphasizes GCP QA audits, risk-based approaches, regulatory readiness, and collaboration with R&D. Travel up to 30% may be required; a Bachelor's degree and 5+ years in auditing are expected.