Director of Quality Assurance
I Peace, Inc.| Cell and Gene Therapy Manufacturing, cGMP iPSCs | CDMO - palo alto, CA
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We are a company that manufactures and sells GMP iPS cells products. We are currently looking for candidates with the following two skills:Knowledge of GMP, with the ability to manage the internal Quality Management System and guide it in the right direction.The ability to accurately understand our internal products and regulatory compliance and effectively explain and market them to external clients.Specifically, we are seeking candidates with experience and knowledge in the following areas:Able to sell and explain our products and services leveraging a deep understanding of Regulatory and Quality compliance5+ years of experience in Quality Assurance with a minimum of 3 years of experience in cell therapy Able to lead discussions and problem solve Quality-related topics internally for both US and Japan sites with QMS compliant with 21 CFR 210211 and ICHQ7Actively manage external consultants and internal stakeholders to identify the appropriate regulatory pathways for new products and services Able to explain regulatory compliance of our products and services, and provide timely support to clients' regulatory filings e.g. IND. Develop and maintain Drug Master Files (DMF)If you enjoy working in a venture environment and love taking on new challenges, this could be the perfect fit. Our venture's philosophy is, "We will either find a way or make one." We are looking for someone who resonates with this philosophy and is excited to join us on the journey to realizing our vision.
Created: 2024-10-20