Description

You will lead clinical quality assurance for oncology trials, ensuring compliance with FDA, EU, ICH, and country-specific regulations. You'll oversee study documentation, audits, and inspections while managing a team and mentoring QA staff.

Requirements

• B.S. in scientific or technical discipline
• 15+ years pharmaceutical clinical quality assurance experience
• Extensive knowledge of ICH E6, FDA, EMA, HC, PMDA regulations
• Experience with phase-appropriate quality systems (Phase 1 to III)
• Experience in regulatory inspections and agency interactions

Responsibilities

• Lead GCP Quality Systems and risk-based audit programs for Phase 3 studies
• Oversee inspection readiness and manage regulatory inspections
• Ensure CAPA plans address findings with effectiveness checks
• Manage external GCP auditors and review audit reports
• Compile and track GCP quality metrics and vendor performance