Auditor I, Clinical Quality Assurance

Responsibilities

• Support GCP/GCLP/GVP audits for investigational sites, internal systems, trial master files, and clinical service providers
• Plan, coordinate, and report audits including the escalation of critical observations
• Assist with commercial inspections and inspection readiness activities
• Support GCP compliance activities including investigations, change controls, and procedure development
• Implement procedures and work instructions based on best practices
• Represent the Clinical Quality Assurance Team in cross-functional projects

Requirements

• BA/BS in life sciences or equivalent field
• 1+ years of GCP or GMP experience
• Knowledge of US CFR, ICH Guidelines, EU, TGA, Health Canada, or MHRA regulations
• Working knowledge of MasterControl, Veeva, or similar eQMS programs
• Proficiency in MS Office (Word, Excel, PowerPoint, MS Project)
• Ability to manage multiple projects simultaneously

About the Company

Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the ability of the human immune system to recognize and attack diverse cancer cells.