Senior QA Clinical Auditor | GCP & Risk-Based Audits

Biopharma Asia; Titusville (FL); Hybride; USD 94 000 - 152 000; Plein temps

Résumé du poste

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization with hybrid work options across Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA. The role reports to a site 3x/week.

In R&D Quality, you will lead risk-based audits and ensure compliance with GCP and regulatory standards while developing CAPAs and supporting inspections.

Qualifications

• Minimum of 5 years auditing, clinical operations, or related field.
• Knowledge of the drug development process, applicable regulations, and quality terminology.
• Knowledge of GCP and applicable regulations/guidelines (FDA, EU CTR, ICH E6 R2).
• Experience conducting Clinical Quality Assurance audits of investigator sites or studies.
• Strong documentation, CAPA, and risk-management fundamentals.
• Proficient in data analytics and use of standard tools.

Responsabilités

• Lead planning, conduct, and reporting of GCP QA audits.
• Support non-routine audits including investigator site audits.
• Ensure audit plans and tools are applied consistently.
• Analyze data to identify trends and patterns.
• Ensure timely CAPA creation and tracking.
• Prepare training materials and contribute to projects.
• Support regulatory inspections as needed.

Connaissances

GCP Auditing

Clinical QA

Regulatory knowledge

Data analytics

Auditing planning

Cross-functional work

Formation

Bachelor's degree

Outils

Audit tools

Description du poste

Johnson & Johnson is seeking a Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization with hybrid work options across Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA. The role reports to a site 3x/week.

In R&D Quality, you will lead risk-based audits and ensure compliance with GCP and regulatory standards while developing CAPAs and supporting inspections.