Director of Quality Management

Job Summary

A company is looking for a Director, Quality Management Office.

Key Responsibilities

• Provide leadership and oversight for quality and regulatory teams in clinical trials and research projects
• Develop and improve the Quality Management Plan and ensure compliance with regulatory standards
• Manage audits, inspections, and engage with regulatory bodies and sponsors for continuous improvement

Required Qualifications

• Bachelor's or Master's degree in a relevant field
• At least 12 years of experience with a Master's degree or 14 years with a Bachelor's degree in quality and regulatory management
• Expertise in quality assurance and regulatory oversight of multi-site clinical trials
• Proven experience in audit readiness and compliance management
• Preferred: Doctoral degree or relevant certifications in regulatory affairs or quality assurance