Job Description:

Verifies GCP compliance to applicable Standard Operating Procedures (SOPs) and regulations Conducts audits of clinical sites and vendors/suppliers Provides full support to the Quality Management System Conduct external audits at clinical sites and vendor sites Leads process improvement activities and CAPA investigations Reviews clinical quality management plans and provides consultative support to clinical sites (as applicable. Trains junior staff on regulations and quality processes Supports regulatory authority inspections Supports business development activities, as requested

Job Requirements:

Strong knowledge of current GCP regulations Experience with regulatory authority inspections Experience working with Quality Systems for CROs Experience conducting GCP clinical site audits Excellent written/verbal communication skills Proficiency in MS Office