• Senior Director, Design & Delivery, Pharmaceutical…

    Takeda Pharmaceuticals (Boston, MA)
    …LIMS). Knowledge management product (PLM, R&D Search). Drug and Device Management Lab Validation . + Structure and resource product teams based on demand planning to ... maintained in compliance with global regulations (eg, GxP, 21 CFR Part 11, FDA ) and Takeda's quality and risk management standards. + Work closely with architecture,… more
    Takeda Pharmaceuticals (01/09/26)
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  • Associate General Counsel, Healthcare Compliance

    Meta (Boston, MA)
    …complex healthcare fraud & abuse laws, medical device compliance ( FDA ) requirements, and international health regulations. You'll collaborate with cross-functional ... assess and monitor healthcare compliance risks by conducting risk assessments and validation activities. Use insights from these reviews to spot areas for… more
    Meta (01/09/26)
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  • Process Development Senior Scientist - Attribute…

    Amgen (Cambridge, MA)
    …International Conference on Harmonization (ICH), and Food & Drug Administration ( FDA ) guidance documents related to analytical method transfer and validation ... . + Experience in authoring and reviewing regulatory submissions, especially module 3 (Quality) common technical documents for IND/BLA submissions. **What you can expect from us** As we work to develop treatments that take care of others, we also work to care… more
    Amgen (01/07/26)
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  • Equipment Maintenance Technician

    Catalent Pharma Solutions (Chelsea, MA)
    …consumer, and Catalent employee.** **The Role:** + Provide support for validation , calibration, and preventative maintenance of all Good Manufacturing Practices ... experience, preferably in cGMP biopharmaceutical, pharmaceutical, medical device, food, or other FDA regulated industry + Must have basic computer skills - including… more
    Catalent Pharma Solutions (01/07/26)
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  • Principal Engineer, Design Quality - Software

    Olympus Corporation of the Americas (Westborough, MA)
    …Affairs' efforts in creating submission materials for various regulatory domains including FDA , PMDA, and EU-MDR. **Job Duties** + Advise SW development teams on ... and activities for the inclusion of ML/AI development, cloud infrastructure, and validation best practices. + Collaborate on the update of SDLC and operations… more
    Olympus Corporation of the Americas (01/06/26)
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  • Design Control Engineer III

    Pfizer (Andover, MA)
    …trials and commercial licensures. + Provide input and support for design validation , including but not limited to human factors engineering assessments. + Support ... (GMP) **Nice To Have** + Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes/injectors, luer connectors, and quality… more
    Pfizer (01/04/26)
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  • Senior Clinical Research Director, I&I

    Sanofi Group (Cambridge, MA)
    …development activities (eg pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment) + Contribute to the clinical ... part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health… more
    Sanofi Group (01/04/26)
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  • Quality Control Technician

    North Coast Seafoods (Boston, MA)
    …and routine testing practices, EM Monitoring and basic knowledge of method/equipment validation principle + 1+ years, experience in food manufacturing; seafood or ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit +… more
    North Coast Seafoods (01/01/26)
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  • Manufacturing Lead Associate - Nights

    Takeda Pharmaceuticals (Lexington, MA)
    …of all routine and critical operations, including commissioning and validation activities; monitor material consumption and coordinate all material deliveries. ... etc. + Knowledge of cGMP's and applicable agency regulations (such as the FDA , EMEA) to ensure inspection readiness of department. + Demonstrates appropriate level… more
    Takeda Pharmaceuticals (12/31/25)
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  • Sr. Sterility Assurance Scientist

    Integra LifeSciences (Mansfield, MA)
    …cover sterilization programs across sites. + Obtains and maintains knowledge of FDA , ISO, and EN sterilization and related microbiology standards and guidelines, for ... audit, and environmental monitoring programs as necessary + Creates and finalizes validation protocols and report ensuring they are clear, concise and compliant to… more
    Integra LifeSciences (12/30/25)
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