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ABOUT THE FLOCKJoin bluebird bio’s enthusiastic and collaborative Quality Assurance (QA) team to contribute to the overall success of our novel gene therapies. Providing Quality Assurance support to bluebird bio’s CMC and Tech Transfer teams.
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Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy (deep experience with GLP or GCP preferred.
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The Senior Manager, Validation, Cell Therapy Quality will report to the Director Cell TherapyProduct Quality and promotes and oversees the quality assurance processes for the Facilities, Equipment, and Validation Lifecycle, including computerized systems, in the Cell Therapy Manufacturing Facility.
$209,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Our Engenious gene therapy platform is the first to precisely engineer any or all hematopoietic and immune cells with a one-time, off-the-shelf in vivo treatment. Experience with Preclinical to Phase 2 stage product development with Gene and Cell Therapy products.
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BS in a scientific or engineering discipline with minimum of 8 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility, with at least 2 years conducting internal and external audits.
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Demonstrated experience in Quality Operations functions within a GMP facility of cell/gene therapy products or biologics in both clinical and/or commercial settings. 8+ years of experience in the pharmaceutical or biotechnology industry in Quality Assurance or Quality Systems or equivalent combination of education and work experience.
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The Manager, Quality Assurance is responsible for the development and management of the Quality Assurance team at Forge Biologics. Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Mission As the Quality Assurance Validation Manager, you will play a pivotal role in ensuring the highest standards of quality and compliance. Title: Quality Assurance Validation Manager.
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Precigen is seeking a detail-oriented and skilled Quality Assurance Manager/Sr Manager to work with our QA Compliance team. Experience in QA support of biologics manufacturing and compliance; experience in Gene Therapy and/or Cell Therapy is a plus.
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The ideal candidate is an expert in the documentation needed for the development and commercialization of a cell & gene therapy manufacturing tool and is also comfortable as the externally facing regulatory expert with customers and strategics.
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Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. 3+ years of experience in GMP Quality Assurance and/or similar role.
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Manages Gene Therapy Supplier Audit Schedule and Annual audit planning; tracks Supplier Complaints and CAPA to closure in a timely manner; responsible for managing BU use of the Global TrackWise Supplier quality modules; responsible for and administers the Risk management system and track completion of risk assessments.
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Conduct risk assessments within various GxP spaces, including medical devices and cell and gene therapy areas. The role also entails deep and broad understanding of GxP regulations including those that apply within the medical devices and cell and gene therapy areas.
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Manages, coaches and develops the QA staff responsible for Supplier Quality Management across the Catalent Gene Therapy sites. This role manages the Supplier Quality team which supports all Catalent Gene Therapy sites.
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4-6 years of experience in Quality Assurance/Systems, or related role within the biotech/pharmaceutical and/or cell/gene therapy industries. Quality Systems & Compliance (QS&C) Sr. Manager will be responsible for the implementation, maintenance, continuous improvement, effectiveness, and compliance oversight of Adicet's Quality Management System (QMS.
$187,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
quality assurance manager gene therapy jobs Title: quality manager
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