Qualifications

• Bachelor's Degree in a relevant field.
• Strong knowledge of current GCP regulations.
• Experience conducting GCP clinical site audits.
• Experience with regulatory authority inspections.
• Proficiency in MS Office and quality systems for CROs.
• Excellent written and verbal communication skills.

Responsibilities

• Verify GCP compliance with SOPs and regulations.
• Conduct audits of clinical sites and vendors.
• Support the Quality Management System.
• Lead process improvement activities.
• Train junior staff on regulations and quality processes.
• Conduct external audits at clinical and vendor sites.
• Assist in business development activities as needed.

Benefits

• Full-time position with potential for travel up to 75%.
• Opportunity to work in a dynamic quality assurance environment.