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The Sr Manager, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Clinical Studies.
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Provide QA Validation support and expertise to CMC and Tech Transfer teams. Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Extensive understanding of GxP, Quality Systems and Pharmaceutical responsibilities with experience as a QA Lead or Representative. Quality Assurance Manager. Inform in timely manner the escalation of any deviation or major or critical complaints to direct manager or the VP Quality Pharmaceutical Development.
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Conduct QA in the company's programs, including ensuring Data Integrity in processes, data packages and reports to the Company's external pharma and gene therapy partners. Interacting, reporting, and collaborating with PGN Global QA team.
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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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Guiding the QA Manager to author Agile test plans and requirements traceability by confirming testing depth (# of test cases) and breadth (types of test cases) are commensurate with the number of story points/complexity and effort intensiveness of the functionalities being developed and tested.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Quality Assurance (QA) Manager (Senior Manager, DOE) Minimum of 8 years of Quality Assurance experience in biopharmaceutics with a minimum of 3 years in human cell therapy platforms.
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BostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. ● 5+ years of QA experience in a GCP setting for any phases of clinical trials in biotech or pharma required.
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The Associate Director/Senior Manager of Clinical Quality will develop, manage, and improve existing quality systems to ensure appropriate controls for EyePoint in-house GCP and GLP capabilities.
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Kelly Science is seeking a Quality Assurance Manager for a client located near Burlington, MA. Minimum of 5+ years of progressive Quality experience working in regulated environment preferably in the field of biotechnology, biopharma, and/or cell/gene therapy.
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The Manager will oversee GCP activities across various areas of development, ensuring compliance, and quality execution of clinical trials. Our Clinical Quality team is growing, and we are currently recruiting for a Manager/Sr. Manager of GCP Clinical Quality Assurance.
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We are looking for a Manager, Quality Engineering to work with global teams and push the envelope on Software Quality automation and agility initiatives. The Manager, Quality Engineering is expected to be a key driver to continue moving the teams to the next level.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Provide proactive GCP QA support for clinical development to ensure patient safety, data integrity, compliance, and operational excellence. Provide QA review of various procedures, clinical protocols, investigators brochure, clinical study reports and other relevant documents as needed.
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The Client Solutions Manager - Quality must have a proven track record in leading the development of business requirements in a client-based setting. The Client Solutions Manager will be encouraged to remain current with market trends by participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations.
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Serve as GMP/GDP interface to vendor QA partners in support of quality management, inspection readiness and continuous improvement. Guide Vertex QA teams and stakeholders to assess risk management strategies, vendor selection /remediation, and quality metrics monitoring.
$124,800 - $177,200 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago
qa manager jobs Title: quality manager in Waltham, MA
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