Description

You will lead clinical quality assurance for a clinical-stage biotech, ensuring GCP, GPvP, and GLP compliance across clinical trials. You'll act as a strategic partner to clinical teams, oversee audits, manage CAPAs, and drive inspection readiness.

Requirements

• Hands-on expertise in GCP, GPvP, and GLP QA operations
• Experience in clinical-stage biotech or pharma
• Proactive problem-solving and ability to guide cross-functional teams
• Knowledge of global regulations and ICH guidelines
• Leadership experience in quality assurance

Responsibilities

• Provide hands-on QA oversight of clinical trial documents (protocols, ICFs, CSRs)
• Act as GCP/GPvP/GLP QA subject matter expert and point of contact
• Develop and execute risk-based audit strategy
• Lead identification, investigation, and resolution of quality issues via CAPA
• Drive inspection readiness and support regulatory interactions