• Senior Manager, Global Product Quality - Biologics

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …support OPDC R&D products; including LIMS data, method development & validation , method transfers and testing (release, stability). + Maintains KPIs/quality metrics ... Thorough understanding of GMP requirements and the Drug Development process. + Knowledge of FDA 21 CFR Parts 210 and 211. + Experience with Pre Approval Inspections… more
    Otsuka America Pharmaceutical Inc. (12/03/25)
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  • Senior Clinical Research Director, Rare

    Sanofi Group (Cambridge, MA)
    …Briefing regulatory documents, Common Technical Document for submission to regulatory bodies ( FDA , EMA, PMDA etc ) and answers to questions from health authorities. ... EC/IRBs, sites + Ensure quality of clinical data through continuous data validation , blinded Data review on summary tables or electronic data visualization during… more
    Sanofi Group (12/02/25)
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  • Senior/Principal Engineer, Combination Products…

    Takeda Pharmaceuticals (Cambridge, MA)
    …subject matter expert (SME), you will lead major technical transfer and validation projects related to new product development, launches, and lifecycle management. ... and manufacturing. + Strong understanding of design control and regulatory requirements ( FDA , EMA, ISO, USP) for combination products and devices. + Experience in… more
    Takeda Pharmaceuticals (11/05/25)
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  • Engineer: Process Improvement Engineer

    Nanobiosym, Inc. (Cambridge, MA)
    …the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with details of ... root cause analysis. + Utilizes DOE/DRM/COS/Lean principles and statistical process control to develop creative, thorough and practical technical solutions. + This is a hands-on position in a growing organization and an opportunity which will grow rapidly +… more
    Nanobiosym, Inc. (11/03/25)
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  • Manager, PVRM

    Sumitomo Pharma (Boston, MA)
    …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
    Sumitomo Pharma (10/30/25)
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