Director of Quality Management

Job Summary

A company is looking for a Director of Quality Management to oversee quality assurance and regulatory compliance in clinical research.

Key Responsibilities

• Manage resource allocation and training for Quality Management staff
• Facilitate regulatory inspections and audits, ensuring compliance with GXP and regulatory standards
• Develop and implement the annual audit plan and oversee quality assurance audits documentation

Required Qualifications

• College or university degree; MD, PharmD, or life sciences degree is a plus
• Minimum 7 years of experience in Clinical Research
• Minimum 5 years of experience as a QA auditor or equivalent
• Excellent knowledge of ICH GCP guidelines, FDA/EMA regulations, and applicable local regulations
• Intermediate proficiency in MS Office (Word, Excel, PowerPoint, Outlook)