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8+ years of audit (internal and/or external), quality assurance/review, internal controls and assurance, risk management, corporate governance, compliance and/or related experience required, with heavy preference for highly substantive audit, assurance, and internal controls experience.
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Implement best practices in data management, ETL processes, and data quality assurance to maintain high standards of data integrity and reliability in Takeda Research. You will also work with scientists and with experts in data management, lab automation, molecular design, and machine learning in the Global Biologics organization to build and continuously improve data infrastructure.
$234,300 a yearFull-timeExpandUpdated 12 days ago - UpvoteDownvoteShare Job
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The Director, R&D Quality, GCP consults as necessary with quality and study teams on advanced GCP quality assurance oversight and management activities to ensure the highest level of compliance in Vertex CGT clinical trials are in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System.
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Work closely with DTE Compliance, Internal Audit, and Quality Assurance groups as needed to ensure compliance with all appropriate regulations, as well as our DTE system lifecycle and change management requirements.
Full-timeExpandUpdated 29 days ago - UpvoteDownvoteShare Job
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The Senior Director of R&D Quality Assurance is responsible for establishing and implementing the strategy for the R&D QA function that provides Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practices (GLP) quality oversight at Apellis.
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Collaborates with GCP Operational Quality, PMSO (Reg. Intel) and Audits, Inspection Management and relevant stakeholders to define regulatory inspection readiness strategy. Serves as a key technical resource for the application of GCP principles in areas such as patient engagement and ethics, quality risk management/ mitigation, and subject privacy to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.
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And/or clinical quality assurance (e.g., GCP auditor) background, with an interest in Trial Master File and inspection readiness. As the Director, Clinical Documentation and Systems Operations, reporting to the Vice-President, Clinical Development Operations, you will lead and support Trial Master File (TMF) activities with the clinical study teams and be the study document subject matter expert (SME), advising and guiding clinical study teams on management of clinical trial study documents.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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We are seeking an experienced QA professional to support and evolve the quality management systems at our ProtaGene US Site in Burlington, MA. This individual will work in a fast-paced, high-growth CRO environment serving leading pharma in biologic development and cell & gene therapy.
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Proven expertise in GCP/GMP regulations and standards, with a deep understanding of how these regulations apply to vendor management and quality assurance. A minimum of 8 years of experience in quality management within the pharmaceutical, biotechnology, or related industry.
Full-timeExpandApply NowActive JobUpdated 30 days ago - UpvoteDownvoteShare Job
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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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You are responsible for managing and supervising scientists and associate scientists and participating in histology related activities / experiments in mouse and non-human primate animal models, in addition to assurance of proper experimental conduct to ensure data quality and integrity.
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Work with scientists across Global Biologics to develop and build end-to-end data management capabilities for biologics discovery. Owns the data accuracy, quality & governance for Global Biologics; accountable for supporting reporting, analytics and the user community.
$234,300 a yearFull-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Exceptional leadership and people management skills. Join Takeda as an Associate Director where you will help develop the vison, strategy, roadmap and execution of building, maintaining, and continuous learning for all data and analytics platforms in Global Biologics.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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This position will work closely with key stake holders including Clinical Operations, Clinical Development, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO's), and Contract Research Operations (CRO's) to ensure seamless supply of Clinical Trial Material.
Full-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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Works in close collaboration with the Project Management and CMC teams and related functions, including discovery, non-clinical development, formulation development, analytical development, Quality Assurance and CMC Regulatory affairs.
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quality assurance management jobs Title: director in Cambridge, MA
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