Quality Assurance Director

Job Summary

A company is looking for a Quality Assurance Director.

Key Responsibilities

• Provide leadership and oversight for quality and regulatory teams supporting various research projects
• Develop and improve the Quality Management Plan and Standard Operating Procedures, ensuring compliance with regulatory standards
• Manage audit and inspection programs, engaging with regulatory bodies and leading continuous improvement efforts

Required Qualifications

• Bachelor's or Master's degree in a relevant field such as biomedical science or public health
• 12 years of experience with a Master's degree or 14 years with a Bachelor's degree, including 6 years in a leadership role
• Expertise in quality assurance and regulatory oversight of multi-site clinical trials
• Proven experience in audit readiness and compliance management in research environments
• Preferred: Doctoral degree in a relevant field and certifications such as RAC or ASQ CQE/CQA