PRINCIPAL, QA

About the role

This position ensures GCP compliance with applicable Standard Operating Procedures (SOPs) and regulations, conducts audits, supports the Quality Management System, and leads process improvement and CAPA investigations.

Responsibilities

• Conduct audits of clinical sites and vendors/suppliers
• Provide full support to the Quality Management System
• Perform external audits at clinical sites and vendor sites
• Lead process improvement activities and CAPA investigations
• Review clinical quality management plans and provide consultative support to clinical sites
• Train junior staff on regulations and quality processes
• Support regulatory authority inspections
• Support business development activities, as requested

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 and verbal communication skills
• Proficiency in MS Office