Michal Inbar Email & Phone Number

With over 17 years of extensive experience in the biotech and medical device industry, spanning various roles and divisions, I bring a holistic approach to quality management and continuous organizational improvement.My expertise particularly shines in the dynamic field of cell and gene therapy startups. I possess a profound understanding of GMP cleanrooms, manufacturing processes, QC laboratories, regulatory compliance, and operational strategies within this industry.In my current role, I hold responsibility for supervising all quality assurance activities, providing robust support for GMP processes. This encompasses tasks such as training, review of controlled documents, leading change control processes, deviations, risk assessments, and CAPA. Additionally, I take charge of writing procedures and protocols while mentoring others in this capacity. Furthermore, I contribute expert perspective to support process development, clinical operations, and manufacturing departments. Additional activities and expertise include QA support for regulatory submissions and overseeing cGMP cleanroom setup and validation.