Julie Quinn Husek
About Julie Quinn Husek
Julie Quinn Husek serves as the Director of Quality Metrics at Mirati Therapeutics, bringing over seventeen years of experience in the pharmaceutical and biotech industries. Her background includes roles at notable companies such as Sandoz, Bristol Myers Squibb, and Novartis, where she developed expertise in quality assurance, incident management, and regulatory compliance.
Current Role at Mirati Therapeutics
Julie Quinn Husek serves as the Director of Quality Metrics at Mirati Therapeutics. She has held this position since 2021, contributing to the organization's commitment to maintaining high-quality standards in its operations. Her role involves overseeing quality metrics and ensuring compliance with industry regulations.
Previous Experience in Quality Assurance
Prior to her current role, Husek accumulated extensive experience in quality assurance across several prominent pharmaceutical companies. She worked as a QA Manager at Sandoz from 2015 to 2017, and as a Global Process Lead at Bristol Myers Squibb for eight months in 2021. Additionally, she held positions at Johnson & Johnson and Novartis, focusing on quality incident management and compliance.
Educational Background
Husek holds a Master of Arts (M.A.) degree from the University of Scranton, which she completed in 2004. She also earned a Bachelor of Science (B.S.) degree from the same institution, graduating in 2003. Her educational background has provided her with a solid foundation for her career in quality assurance and regulatory compliance.
Expertise in Quality Systems and Compliance
Husek possesses over seventeen years of experience in FDA-regulated environments, focusing on critical incident management, batch disposition, and GMP compliance activities. She is skilled in developing and implementing quality and compliance remediation plans, particularly in response to Consent Decree requirements. Her proficiency extends to various software programs essential for quality management.
Training and Certifications
Husek is trained in Lean Six Sigma and holds a Yellow Belt certification. She is proficient in ICH guidelines and CFR 21, Part 210 and 211, which govern pharmaceutical manufacturing practices. Her training supports her ability to drive continuous improvement in quality systems and ensure adherence to regulatory standards.