• Compliance Head, US FDA

    Sanofi Group (Framingham, MA)
    …Team + **Lead cGMP compliance projects** aligned with the company's Quality Operations strategy and US FDA regulations. + **Drive digital transformation ... **Job Title:** Compliance Head- US FDA **Location** :...**Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing of US FDA… more
    Sanofi Group (06/03/25)
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  • Manager, Quality Assurance & Regulatory

    Tecomet (Woburn, MA)
    …and improve quality systems/programs, reduce quality costs and maintain compliance within FDA and ISO regulations. This is accomplished by maintaining ... Correspondent. + Serve as person responsible for regulatory compliance (PRRC). + Assist and complete site FDA...procedures to ensure is in compliance with FDA 21 CFR, Part 820, Quality System… more
    Tecomet (07/31/25)
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  • Head Of Quality

    Actalent (Lexington, MA)
    … Quality team. Required Skills: + Quality Assurance + Audit Management + FDA Compliance + CAPA Oversight + GMP/GxP Knowledge + CDMO Experience Top Skills: ... Description: Lead and oversee the Quality team, ensuring robust compliance with...Quality Assurance (QA), including audits, CAPA oversight, and FDA readiness, while maintaining and improving QA systems across… more
    Actalent (07/26/25)
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  • Engineer, Quality

    ManpowerGroup (Westford, MA)
    …the Job?** + Initiate and oversee medical device quality assurance activities in compliance with FDA Quality System Regulation and ISO13485. + Develop ... a leader in the medical device industry, is seeking a Quality Engineer to join their team. As a Quality Engineer, you will be part of the Sustaining Quality… more
    ManpowerGroup (07/03/25)
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  • Senior Quality Compliance Specialist…

    Integra LifeSciences (Braintree, MA)
    …what's possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs ... matrices with each of the groups to ensure both compliance and business needs can be met, including appropriate...of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016,… more
    Integra LifeSciences (05/09/25)
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  • Associate Director, Clinical and Safety…

    Takeda Pharmaceuticals (Boston, MA)
    …knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the quality of ... + Contributing to the design, implementation and advancement of the Clinical and Safety Quality Compliance strategy, model, and operations as a key member of the… more
    Takeda Pharmaceuticals (07/25/25)
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  • Senior Global Patient Safety Quality…

    United Therapeutics (Boston, MA)
    …you're passionate about pharmacovigilance! You are a team player who loves quality , compliance , finding solutions and ensuring training standards are implemented ... This role in Global Patient Safety (GPS) will focus on enhancing and maintaining quality , training, and compliance (QTC) of GPS operations and practices. They… more
    United Therapeutics (07/12/25)
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  • Auditing & Compliance Director - Software…

    Wolters Kluwer (Waltham, MA)
    …the company. You will report to the VP, Clinical Content Management **RESPONSIBILITIES** ** Quality Management and Compliance ** + Maintain and monitor Quality ... (SOPs/WIs) in compliance with ISO 13485, US Quality System Regulation for SaMD regulated by the FDA , and EU MDR. + Perform design control activities focused… more
    Wolters Kluwer (06/11/25)
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  • Senior Manager Trade Compliance (Remote)

    Charles River Laboratories (Wilmington, MA)
    …you can feel passionate about. **Job Summary** The Sr. Manager, Global Trade Compliance , will provide trade and Customs support to CRL's global business units. In ... will report directly to the Director of Global Trade Compliance and will oversee the day-to-day management of the...origin determination, and all participating government agency requirements (ie FDA , USDA/APHIS, FWS, CDC, EPA) * Oversee the Post… more
    Charles River Laboratories (08/01/25)
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  • Head Of Quality

    Actalent (Lexington, MA)
    …Top Skills: + Quality Assurance Leadership + Audit & Inspection Management + FDA Compliance + CAPA Oversight + GMP/GxP Expertise + CDMO Operational Knowledge ... Quality Assurance (QA) leader to oversee our Quality team and ensure compliance with regulatory...quality systems in accordance with GMP, GxP, and FDA requirements. + Oversee CAPA processes, ensuring timely and… more
    Actalent (07/30/25)
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