The GMP Quality Operations Manager is recognized internally as an expert in the principles and application of quality assurance, compliance, and AI-enabled quality operations. The Quality Manager will provide QA supportofmanufacturing operations for the external manufacture of Cell & Genetic Therapeutic programs. This role will support activities related to product disposition, including review of batch data, batch records, deviations, in-process data, EM data, QC release testing, and other quality systems documentation, while advancing intelligent digitized solutions for backlog triage, metrics generation, records reconciliation, and archiving to improve operational efficiency, compliance, and data integrity.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and has made significant advancements in cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, and acute pain — and continues to progress clinical and research programs in these diseases. We also have a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where we have deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Our global headquarters is in Boston, and we have research and development (R&D) sites and commercial offices worldwide. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. We have also earned a spot on TIME Most Influential Companies, TIME Best Inventions, and Fast Company Most Innovative Companies lists. Our research and medicines have received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the Prix Galien, the Scrip Award and the Breakthrough Prize awards. Read our community guidelines: https://www.vrtx.com/vertexs-community-guidelines/
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