• Senior Manager Cleaning Validation

    Bristol Myers Squibb (Devens, MA)
    …of cleaning processes. + Ensure compliance with regulatory guidelines (FDA, EMA, cGMP , ICH) and internal SOPs. + Participate in audits and inspections, providing ... lifecycle maintenance, and responding to compliance requirements. + Strong knowledge of cGMP , FDA, EMA, and ICH cleaning validation requirements. + Experience with… more
    Bristol Myers Squibb (10/16/25)
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  • Senior Specialist, Quality Assurance

    Cardinal Health (Boston, MA)
    …documentation in accordance with current Good Manufacturing Practices ( cGMP ), FDA regulations, and internal procedures. **_Responsibilities_** **Labeling Review ... in related field, or equivalent work experience, preferred + Working knowledge of cGMP and FDA regulations. + Experience with quality management systems and labeling… more
    Cardinal Health (10/15/25)
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  • Quality Control Analyst II

    Catalent Pharma Solutions (Chelsea, MA)
    …dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is ... investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required + Ability to troubleshoot and repair analytical instrumentation such… more
    Catalent Pharma Solutions (10/15/25)
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  • MicroCleaner

    Controlled Contamination Services LLC (Waltham, MA)
    …and correctly. + Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement. + Normal responsibilities ... follow through on corrective and preventative actions (variances). + Review change to cGMP documentation and re-train. + Assist in the cross training of other… more
    Controlled Contamination Services LLC (10/14/25)
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  • Senior Director, MSAT Biologics

    Otsuka America Pharmaceutical Inc. (Boston, MA)
    …recommending and implementing innovations where appropriate + Ensure compliance with cGMP regulations and other relevant quality standards + Represent the MSAT ... scale-up, and technology transfer of biologics products + Strong knowledge of cGMP regulations and ICH guidelines relevant to biologics manufacturing + Experience… more
    Otsuka America Pharmaceutical Inc. (10/13/25)
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  • Senior Specialist, Quality Assurance Shop Floor,…

    Bristol Myers Squibb (Devens, MA)
    …to ensure GxP compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . In the capacity of QA Shop Floor, the Senior Specialist shall ... education and work experience may be considered. + 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience. Experience in… more
    Bristol Myers Squibb (10/12/25)
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  • Director, Analytical Sciences

    Editas Medicine (Cambridge, MA)
    …and Change Controls). The position requires a strong knowledge of cGMP /ICH/FDA/EMA regulations and regional pharmacopeia. This position will operate in a ... contract organizations to develop and implement analytics to support clinical cGMP manufacturing (in-process, release and stability testing). + Manage phase… more
    Editas Medicine (10/12/25)
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  • Quality Assurance Associate

    Actalent (Fall River, MA)
    …supports compliance with established specifications, current Good Manufacturing Practices ( cGMP ), and Standard Operating Procedures (SOPs). Shift: Second Shift - ... Proficient in Microsoft Office, SAP, and other business applications + Knowledge of cGMP standards + Self-starter with initiative to seek training or guidance +… more
    Actalent (10/11/25)
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  • Manager, Operational Excellence, Cell Therapy in

    Bristol Myers Squibb (Devens, MA)
    …readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations. + Review and revise the content of technical documentation (eg ... Management principles is highly desirable. + Solid understanding of cGMP 's and multi-national biopharmaceutical/cell therapy regulations. + Experience working with… more
    Bristol Myers Squibb (10/10/25)
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  • Head of Medical Device & Software as Medical…

    Takeda Pharmaceuticals (Lexington, MA)
    …and articulate appropriate strategies and activities to ensure compliance to cGMP regulations and expectations. + A comprehensive understanding of pharmaceutical ... decisions on quality issues and product disposition, ensuring patient safety and cGMP compliance. + Analyzes complex data and applies judgment to make timely… more
    Takeda Pharmaceuticals (10/10/25)
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