• Sr Manager, IT Business Analysis - SAP BRH…

    Gilead Sciences, Inc. (Raleigh, NC)
    …deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA), and life sciences Quality Management and Batch Release processes. As an ... Life Sciences manufacturing operations, ensuring alignment with industry regulations such as GxP , FDA, and 21 CFR Part 11. Design scalable, efficient, and compliant… more
    Gilead Sciences, Inc. (07/10/25)
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  • Executive Director, Global GMP Auditing

    Merck (Raleigh, NC)
    …contractors, and suppliers. **Primary Responsibilities:** + Lead global team of GxP auditing experts to ensure our company's manufacturing sites, contractors, and ... ensure their ongoing skills development and ability to detect and communicate GxP compliance concerns + Ensure fiscal responsibility while maintaining budget for… more
    Merck (08/22/25)
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  • Strategic Development Clinical Oversight Manager

    United Therapeutics (Research Triangle Park, NC)
    …development and implementation of department Inspection Readiness plan + Collaborate with GXP Compliance/QA to identify trends resulting from GXP Compliance/QA ... audits + Support clinical team in preparing for inspections + Facilitate GXP Compliance/QA audit activities for clinical development to include root cause analysis,… more
    United Therapeutics (08/22/25)
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  • LIS Coordinator

    CBRE (Raleigh, NC)
    …relocations. + Ensure customer requirements are met based on review of GxP pipette or similar instrument certificates/tests records provided by third-party service ... Provide training support and backup to department personnel for the review of GxP pipette or similar certificates and test reports. + Follow standardized procedures… more
    CBRE (08/14/25)
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  • Quality Assurance Senior Associate

    Pfizer (Sanford, NC)
    …release data. + Ensure regulatory compliance with current Good Manufacturing Practices ( GxP ) and provide Quality Review and oversight of site documentation to meet ... + Solid understanding of current Good Manufacturing Practices and relevant GxP regulations + Experience in quality administered systems + Strong organizational… more
    Pfizer (08/12/25)
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  • Sr. Tech, Operations

    Merck (Durham, NC)
    …compliance with established company, department, and safety policies and procedures within GXP -regulated and non- GXP facilities. The incumbent will execute daily ... work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls. The individual in this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or… more
    Merck (08/09/25)
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  • Lead Maintenance and Instrumentation Technician

    Merck (Durham, NC)
    …compliance with established company, department, and safety policies and procedures within GXP -regulated and non- GXP facilities. The incumbent will execute daily ... work assignments and ensure timely completion of all scheduled and unscheduled events for instrumentation systems controls. The individual in this role will collect, compile, measure, summarize, and record data obtained during scheduled calibration and/or… more
    Merck (08/09/25)
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  • Service Delivery & Vendor Manager

    Chiesi (Cary, NC)
    …compliance with relevant internal policies and external regulations (eg, HIPAA, GxP ), especially in third-party services + Accountable for Application Management ... access, incident response roles), and supports third-party assessments under HIPAA, GxP , and corporate security policies Education Bachelor's degree in IT, Business… more
    Chiesi (08/08/25)
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  • Director - IT Architecture

    IQVIA (Durham, NC)
    …on scalability, modularity, interoperability, and compliance with life sciences regulations (eg, GxP , HIPAA, 21 CFR Part 11). The Director will partner with ... modern API/microservices architectures + Strong understanding of regulatory standards (eg, HIPAA, GxP , 21 CFR Part 11) and clinical data structures (eg, CDISC, HL7,… more
    IQVIA (07/03/25)
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  • Calibration Technician

    ManpowerGroup (Raleigh, NC)
    …+ Complete calibrations, qualifications, and preventive maintenance with accurate GxP documentation. + Develop and maintain strong client relationships through ... of pharmaceutical equipment. + Strong understanding of regulatory compliance and GxP documentation. + Ability to work independently and manage multiple tasks… more
    ManpowerGroup (06/26/25)
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