▷ (Inicio Inmediato) Associate Director Quality Assurance...

Overview

Senior GCP Auditor – Remote at BioPhase Solutions

The Senior GCP Auditor ensures compliance with SOPs, ICH GCP E6 (R2), FDA regulations, and study protocols. This role supports inspection readiness and collaborates cross-functionally with Clinical Operations, Regulatory, PV, Medical Writing, and Data Management.

Compensation

$130,000.00 / yr - $145,000.00 / yr

Responsibilities

• Maintain and update the Clinical Trial Quality Management System.
• Plan and conduct internal, vendor, and clinical site audits.
• Prepare audit documentation and follow up on findings and CAPAs.
• Review protocols, ICFs, and study-related documents for compliance.
• Support GCP training and quality issue resolution across departments.
• Track deviations, CAPAs, and complaints.
• Lead inspection readiness initiatives and assist during regulatory inspections.
• Represent QA in cross-functional meetings.

Qualifications

Skills

Additional info

Seniority level

Employment type

Job function

Industries

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