• Vice President, Corporate Quality

    Bristol Myers Squibb (Devens, MA)
    …regulatory experience in GxP environment. + Previous proven experience dealing with FDA and other major regulatory agencies. + Experience with digital innovation, ... managing a large budget. + Experience in Computer System Validation , Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination… more
    Bristol Myers Squibb (12/18/25)
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  • Global Manufacturing Sciences Process Science Lead…

    Takeda Pharmaceuticals (Boston, MA)
    …and/or review key CMC and quality deliverables, such as: + protocols, validation reports, methods, technology transfer reports + investigation reports and technical ... of EU and US CMC requirements and familiarity with inspection expectations (eg, MHRA/ FDA ) and compliance practices. + Ability to travel up to 20%, domestic &… more
    Takeda Pharmaceuticals (12/18/25)
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  • Director, Global Quality GMP Processes

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …+ GMP Compliance: Ensure all quality processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and align with current GMP standards. + Governance & ... electronic quality systems (eg, TrackWise), including configuration, training, and validation . + Cross-Functional Collaboration: Partner with regional quality leaders,… more
    Otsuka America Pharmaceutical Inc. (12/16/25)
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  • Principal Biostatistician

    Edwards Lifesciences (Boston, MA)
    …of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide ... R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA , ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical… more
    Edwards Lifesciences (12/12/25)
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  • Lab Execution Program Lead

    Kelly Services (Raynham, MA)
    …+ Responsible for harmonizing testing, calibration, and maintenance, EHS and validation processes across multiple sites + Responsible for executing, mentoring, and ... participate in industry standards (eg, ASTM, ISO, ASME), regulatory guidance (eg, FDA ) & internal company standards to research, development, and testing projects. +… more
    Kelly Services (12/12/25)
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  • Quality Engineer 2

    Hologic (Marlborough, MA)
    …impact on healthcare innovation. **Knowledge:** + In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product ... Strong technical writing skills for preparing and reviewing technical reports, validation documentation, and quality records. + Analytical skills to compile,… more
    Hologic (12/11/25)
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  • Senior Firmware Engineer, Abiomed

    J&J Family of Companies (Danvers, MA)
    …for mechatronics products. + Experience with contract manufacturing, PCB design/ validation , and lab equipment. + Experience with in-circuit emulators, JTAG ... laboratory test equipment such as oscilloscopes etc. + Knowledge of regulatory ( FDA , EPA) and quality processes. + Experience with software configuration management… more
    J&J Family of Companies (12/09/25)
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  • Director, Training Management Operations…

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …experience and compliance tracking. + Ensure data integrity and system validation in accordance with GxP requirements. **Operational Excellence** + Lead global ... + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS administration, data analyics, and process… more
    Otsuka America Pharmaceutical Inc. (12/06/25)
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  • Human Factors Engineering - Associate Engineering…

    Takeda Pharmaceuticals (Lexington, MA)
    …use-safety engineering through Use-related Risk Analysis. + Developing Human Factors Validation Protocols and Reports. + Managing Human Factors, Industrial Design, ... Information Requests. + Developing Human Factors Summary Reports in compliance with FDA guidance. + Developing Usability Engineering Files in compliance with IEC and… more
    Takeda Pharmaceuticals (12/05/25)
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  • Capital Project Engineer

    AbbVie (Worcester, MA)
    …renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA /GMP regulated environment. Responsible for the engineering and management of ... (FAT / SAT) protocols + Participates in biopharmaceutical and pharmaceutical validation activities of equipment, facilities and utilities to ensure the system… more
    AbbVie (12/04/25)
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