Director, Quality Assurance and Compliance
Ms. Hawkins is a biopharmaceutical and medical device quality assurance professional with more than 25 years of experience in establishing and overseeing quality management systems to meet US FDA and EU regulatory requirements. Ms. Hawkins joined IDRI in 2010 as Director, Quality Assurance and Compliance and as part of the original GMP operations team. Previous experience includes Vice President of Quality and Regulatory, Vice President of Quality and Director of Quality Assurance for Dharma Therapeutics, Seattle, WA, 5 years; Quality Assurance Supervisor and Quality Assurance Engineer for Xcyte Therapies, Seattle, WA, 4 years; Quality Assurance Manager, Intracel Corporation, Issaquah, WA, 4 years; and Quality Assurance Manager, Molecular Probes, Eugene, OR, 3 years. Ms. Hawkins’ experience includes quality control and quality assurance for clinical and commercial regulated drug and medical device products, quality system design and management, and ISO 9000 certification. Ms. Hawkins’ education includes a Bachelor of Arts, Biochemistry, University of California, Berkeley, CA (1987); Biomedical Regulatory Affairs Certificate, University of Washington, Seattle, WA and educational courses in ISO 9000 lead auditing, , ISO 13485 implementation, medical device testing and design controls, US FDA and EU GMP regulations for drug and medical device products, and auditing.