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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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We are looking for an experienced Quality Assurance (QA) professional to join our team as QA Operations Manager supporting our internal GMP Cell therapy manufacturing. Support training program for QA operations specialists which include training curricula, raw material dispositions, batch issuance, and batch record review and release training curriculum as well as operational quality systems and compliance.
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Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA. Up to 20% domestic travel required.
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The Configuration Manager will provide support ranging across the Configuration Management (CM), Quality Assurance (QA), Program Planning (PP), Risk Management (RM), and System Engineering (SE) activities which will vary depending upon the current activities of the program/system, scope of the current development/sustainment cycle, and other corporate and program initiatives.
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Extensive understanding of GxP, Quality Systems and Pharmaceutical responsibilities with experience as a QA Lead or Representative. 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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Liaises with key functions including Clinical Operations, Finance, Legal, Biostatistics, PV, QA, Data Management, and Clinical Development to ensure appropriate stakeholder engagement in vendor selection and management.
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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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5+ years of QA experience in a GCP setting for any phases of clinical trials in biotech or pharma required. BostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team.
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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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Interfaces with relevant stakeholders including regulatory affairs, clinical operations, and development sub-teams, as appropriate to provide GCP/GPV and QA expertise. Interface and provide day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
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Negotiates cross-functionally, successfully motivates and influences (Clinical Development, Regulatory Affairs, CMC, QA, Pharmacovigilance, etc.) Cross-functional clinical processes, including data management, biostatistics, medical writing, drug safety/pharmacovigilance, and regulatory affairs.
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Senior Civil Engineering Project Manager. Education and Experience: B.S. or M.S. Degree in Civil or Environmental Engineering with 12 to 15 or more years of experience, including meeting or exceeding the Project Manager job description, with a minimum of 3 or more years of experience in the Project Manager position prior to consideration for Senior Project Manager.
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Reporting to the Corporate VP QA/RA, the Global QA/RA Systems Manager is responsible for providing leadership, planning, project coordination, and management to develop a cost-effective electronic Quality Management Systems (eQMS) and harmonized QA/RA information systems while concurrently facilitating efficient operations to meet current and future business needs.
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Ability to lead QA medical device and combination products compliance and auditing operations, make sound decisions regarding evaluation of cGMP compliance, and leadership ability. for all aspects of QA for Medical Device and combination products manufactured either on site or at third party contract manufacturer.
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qa manager jobs Title: manager in Lexington, MA
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