• Associate Director, MSAT, Downstream Drug…

    Otsuka America Pharmaceutical Inc. (Sacramento, CA)
    …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
    Otsuka America Pharmaceutical Inc. (07/18/25)
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  • Lead Test Automation Architect (Cloud, Web,…

    Abbott (Pleasanton, CA)
    …Assurance: Ensure all test strategies and practices align with medical device regulatory standards ( FDA , ISO, IEC 62304).Support documentation, verification, and ... will collaborate cross-functionally with development, product, operations, quality, and regulatory teams to ensure the delivery of high-quality, compliant software… more
    Abbott (07/16/25)
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  • Head of Quality & Compliance, Monarch Platform

    J&J Family of Companies (Santa Clara, CA)
    …track record of leading and facilitating successful audits and inspections with regulatory bodies including FDA and various Foreign Government Health Authorities ... stewardship, cybersecurity, and product security requirements. + Support the regulatory submission process in compliance with FDA ,...the regulatory submission process in compliance with FDA , EU MDR and other select country regulations and… more
    J&J Family of Companies (08/08/25)
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  • Operations Supervisor - Warehouse & Transfill

    Owens & Minor (Riverside, CA)
    …skills in distribution, logistics, and safety procedures.) * Ensures all Human Resources, Regulatory , Joint Commission, FDA , and Legal training is completed on ... company policies, improving operational performance and compliance with safety, regulatory , quality standards, and resolving customer and operational issues… more
    Owens & Minor (08/21/25)
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  • Senior Director, Innovative Statistics

    Cytel (Sacramento, CA)
    …motivate a strong team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development ... model-informed drug development), to provide strategic advice to define optimal regulatory , clinical and/or market access pathways and promote faster patient access… more
    Cytel (08/12/25)
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  • Staff Quality Engineer

    Stryker (Irvine, CA)
    …+ Medical device industry experience is strongly preferred. + Experience in interacting with regulatory agencies ( FDA , MoH, TUV, etc.). + Understanding of US and ... to enhance quality performance across the business and for customers while ensuring regulatory standards and compliance. **What You Will Do:** + Work closely with… more
    Stryker (08/09/25)
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  • Director, Design Assurance

    Imperative Care (Campbell, CA)
    …+ Lead the design assurance team and ensure compliance with domestic and international regulatory standards (eg, FDA , CE marking, etc.). + Build and sustain ... + Participate in audits by external bodies (Notified Body, FDA , etc.) and internal audits to maintain regulatory... FDA , etc.) and internal audits to maintain regulatory compliance. + Oversee quality and compliance issues, actively… more
    Imperative Care (07/01/25)
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  • Specialist Quality Control Virology

    Bayer (Berkeley, CA)
    …Degree in a science or technical field. * Demonstrable experience with cGMP and regulatory compliance ( FDA , EMA and other international agencies). * Ability to ... follows through until the completion of workflows. + Interacts with regulatory agencies, customers and internal auditors/inspectors. Represents QC microbiology at… more
    Bayer (08/13/25)
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  • Production Specialist II-CSI

    Bayer (Berkeley, CA)
    …New Product Introduction is beneficial; + Strong understanding of data integrity, regulatory requirements ( FDA , EMA, etc.), and cGMP requirements for ... implements effective corrective actions to prevent re-occurrence; + Participates in regulatory or internal audits including presentations to auditors; + Participates… more
    Bayer (08/07/25)
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  • Executive Director, Global Clinical Supply Chain…

    Gilead Sciences, Inc. (Foster City, CA)
    …for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, ... EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses. + Expert in leading through ambiguity, can assess options quickly and… more
    Gilead Sciences, Inc. (06/18/25)
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