Director of Quality Assurance

Job Summary

A company is looking for a Director, Precision Medicine and Diagnostics Quality.

Key Responsibilities

• Develop collaborative partnerships with R&D Leadership to identify quality risks in In-Vitro Diagnostic studies
• Implement innovative quality oversight methods for IVD and Precision Medicine programs, including third-party oversight
• Lead the development of IVD quality management strategies to ensure compliance with regulatory requirements

Required Qualifications

• Doctorate degree with 4 years of relevant experience, or Master's degree with 8 years, or Bachelor's degree with 10 years of relevant experience
• At least 4 years of experience in managing teams or leadership roles
• 7 years of experience in Quality Management or Quality Assurance within the pharmaceutical/biotech industry
• Experience with Quality Management Systems and electronic QMS tools
• Deep knowledge of IVD regulations and Precision Medicine quality requirements