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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.
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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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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.
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The QA/QC Manager will be responsible for the overall quality of the finished project and shall establish and enforce job site quality and quality control programs to ensure quality completion of construction.
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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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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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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 - UpvoteDownvoteShare Job
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The Quality Manager assists and supports Project Engineer, Project Manager, and Superintendent on assigned projects. Working knowledge of regulatory agency QA/QC requirements 10 years of construction experience, with Quality Control Background PE is Required or 15 years experience Bachelor of Science in Construction or Engineering or equivalent experience and minimum 12 years prior relevant experience.
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Join us as the Senior Manager/Associate Director of Quality Assurance at Frontier, where precision meets purpose. If you're ready to bring your analytical prowess to the table, join us and report directly to the head of RA/QA as we navigate the complexities of quality assurance with precision and purpose.
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Our vaccine client here in Boston, MA is growing and looking to add a Manager/Senior Manager of Quality Assurance (QC Support) to their team! A minimum of 5 years' experience in a pharmaceutical/biologics company with at least two (2) in third party manufacturing QA.
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ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events.
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qa manager jobs Title: quality manager in Cambridge, MA
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