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If you are interested or know of someone that would be a great match, please send a MS Word resume to John Marino at John@SourceRecruitmentSolutions.com Source Recruitment Solutions, LLC. Or apply now online by directly clicking the “ APPLY NOW ” link: #Quality #QualityAssurance #QualityAssuranceManager #QualityAssuranceJobs #food #HACCP #SQF #ConsumerProducts #Monster.com.
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Mass General Brigham is seeking a Registered Nurse (RN) Clinic Quality Assurance Senior for a nursing job in Cambridge, Massachusetts. - Monitors staff adherence to designated NCQA UM, NCQA Complex Care Management (CCM), Quality Improvement (QI) and other standards, contractual and regulatory requirements with ongoing assessment of performance.
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Minimum of 10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical Class III devices is required.
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Minimum 10 years in quality assurance management and compliance, ideally with cell therapy/viral quality systems, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
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Subject matter expertise of BSA/AML and Fraud related risks with a focus on data, data quality, data flows and a solid business understanding of application of these risks within a large financial institution.
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M.S. or B.S. BS degree in microbiology, molecular biology, biochemistry or a related discipline with a minimum of 5+ years of experience in a cGMP Quality Control lab at least 1 year in a supervisor role; or equivalent combination of education and experience.
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Support the development and maintenance of company Quality Management System (QMS) and integrated Learning Management System (LMS) and Controlled Document System as appropriate. The role of Manager, Clinical Quality Assurance, supports Quality oversight for Bicycle’s development programs, ensuring compliance with applicable GLP and GCP standards and global regulations.
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Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them. The Vice President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs.
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Providing Quality Assurance support to bluebird bio’s CMC and Tech Transfer teams. Providing Quality representation on internal bbb and external CMO/CLO cross functional teams for development, method transfer, and assay validation projects.
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How you will contribute:Develop and implement data models and algorithms to analyze complex datasets related to pharmaceutical quality and R&D.Leverage generative Artificial Intelligence (AI) and large language models (LLM) to enhance data analysis, automate processes, and produce insights.
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The Senior Manager of Quality Assurance (QA) is accountable for overseeing the GMP cloning operations and Supplier Management Program to be conducted in the eGenesis. B.S./M.S. in Life Sciences or related field with 8+ years of experience, including leadership, in GMP Quality Assurance.
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The position will also support the quality oversight of the Prescription Drug Marketing Act (PDMA) for the company's Commercial product Sample Management. 15-20 years of pharmaceutical industry experience within the Quality/Compliance Oversight of; Drug Safety, Clinical, Regulatory and/or Medical Affairs disciplines.
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The CLIA Quality Manager will collaborate with direct and/or delegated authority to ensure the CLIA Quality Management Systems (QMS) are effective and compliant with applicable requirements, provide leadership and guidance re: CLIA and associated regulations, and support the Lab Director and leadership in maintaining audit readiness.
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This role will develop strong relationships, collaborate, and interact with various departments (i.e., Quality Operations, Quality Systems, Chemistry Manufacturing, and Controls (CMC), Analytical, Regulatory Affairs, Pharmacovigilance, Procurement), and all levels of management at Akebia to accomplish company objectives.
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In-depth knowledge of relevant regulations, guidelines, and best practices governing the quality assurance of drug products, including FDA, EMA, cGMP, and ICH requirements. Oversee and manage the quality assurance team (internal and/or external), ensuring compliance with all applicable regulations and guidelines, like cGMP, ICH, and FDA requirements.
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Title: quality Company: Proactive Strategies in Needham, MA
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