• Novo Nordisk Inc. (Miami, FL)
    …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
    HireLifeScience (03/27/24)
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  • Novo Nordisk Inc. (Los Angeles, CA)
    …and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …site relationships through all-phases of the trial.-Performs clinical study site management /monitoring activities in compliance with ICH- GCP ,-Sponsor SOPs, Local ... CRA manager or CRD, the person ensures compliance of study-conduct with ICH/ GCP and country regulations, our company's policies and procedures, quality -standards… more
    HireLifeScience (03/27/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Computer Systems used to support the end-end GxP Supply chain including the Quality Management System, manufacturing, quality control, warehouse, and ... position will provide end users guidance on Computer Systems utilized to support quality management system activities such as Electronic Document Management more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …of R&D QA. Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and ... research areas centered around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy...other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA … more
    HireLifeScience (02/24/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …clinical project management competencies within Clinical OperationsWork in collaboration with Quality Management and Quality Assurance to develop and ... Clinical Operations staff and to project teams for Vendor evaluation, selection , management and quality based oversightProvide guidance and training to Clinical… more
    HireLifeScience (03/01/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …audienceAt least 8 years' experience in the biotech/pharmaceutical industry in validation, quality management , process controls, and continuous improvement in an ... Position Summary:Oversee and lead the validation program for production equipment and...commercialization. Serve as a technical resource to improve product quality , reliability, and process capability. Support manufacturing to satisfy… more
    HireLifeScience (03/16/24)
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  • Merck & Co. (Upper Gwynedd, PA)
    …scientific planning and execution of one or- more clinical trials. Assists the Lead Clinical Scientist and study team with the- scientific conduct of clinical ... of Protocol and related study materials (eg, ICFdocuments/amendments, data management deliverables).May interact with internal and external stakeholders (eg, country… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (Rahway, NJ)
    …/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and integrity of trial conduct.Providing tactical/scientific ... clinical/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on the clinical trial team.Leading medical monitoring… more
    HireLifeScience (03/26/24)
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  • Insmed Incorporated (San Diego, CA)
    …for Millennials™ lists.OverviewThis Role is responsible for the overall leadership, management , and oversight of phase I-IV clinical trials from protocol concept ... to ensure all studies are delivered on time, within budget and with high- quality data. Leads the cross-functional Clinical Study Team (CST), CRAs, CTAs, to ensure… more
    HireLifeScience (03/12/24)
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  • Eisai, Inc (Nutley, NJ)
    …timelines.Responsibilities include, but are not limited to, serving as the statistical lead on project teams. This involves providing valuable statistical input on ... as needed.Overall, the incumbent is entrusted with the leadership and effective management of statistical activities, contributing significantly to the success of a… more
    HireLifeScience (03/06/24)
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  • Eisai, Inc (NJ)
    management ; providing guidance to study teams on vendor selection and management options in alignment with global strategies. Lead the process of Request ... from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the outsourcing of clinical services to… more
    HireLifeScience (02/01/24)
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  • Good Clinical Practice ( GCP ) Senior…

    GE HealthCare (Boston, MA)
    …may develop and monitor key quality metrics to assess the effectiveness of quality management systems and report findings to senior management and ... functional QA subject matter expert + Participates in the quality management system (QMS) improvements. + Overall,...system (QMS) improvements. + Overall, the role of a GCP Quality Assurance Auditor is multifaceted, requiring… more
    GE HealthCare (02/23/24)
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  • Good Clinical Practice ( GCP

    GE HealthCare (Boston, MA)
    …knowledgeable about their responsibilities and compliant with relevant regulations. + Quality Management System (QMS) Implementation: QA Oversight professionals ... **Job Description Summary** The Good Clinical Practice ( GCP ) Quality Assurance (QA) Oversight role is crucial in ensuring that clinical trials are conducted in… more
    GE HealthCare (02/23/24)
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  • Senior Manager GCP Compliance

    Takeda Pharmaceuticals (Washington, DC)
    …of my knowledge. **Job Description** **_OBJECTIVES/PURPOSE_** + Lead compliance management efforts related to quality events and auditsfor clinical trial ... for projects to address risks and issues + Develop and leadcompliance assessments to address GCP Quality Plan CAPAs/ECs and liaise with QA to ensure adherence to… more
    Takeda Pharmaceuticals (01/17/24)
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  • Gcp Auditor

    Actalent (Raleigh, NC)
    …analytics tools are preferred. * Understanding of fundamentals of clinical trial risk management is required * Experience conducting Quality Assurance audits is ... Description: Actalent is hiring a GCP Auditor for a permanent role. Preferred employees...audits. Inspection Support * Supports regulatory inspections in a lead or supporting role. * Conducts pre-inspection visits and… more
    Actalent (03/18/24)
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  • GCP QA Auditor 2

    IQVIA (Durham, NC)
    …**Manage/oversee quality events updates in eQMS and/or Maintains the electronic quality management system (eQMS) and provides support in relation to the ... and assessment of compliance to regulations, guidelines and corporate policies, lead /support in QA initiatives/projects for quality process improvements.**… more
    IQVIA (03/15/24)
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  • Asset Quality Lead (Director)

    Pfizer (South San Francisco, CA)
    … and general GCP guidance. **ROLE RESPONSIBILITIES** Level 1 GCP Quality : + IQMP (Integrated Quality Management Plan) Development and Oversight at ... Oncology clinical portfolio. + With this focus, the Asset Quality Lead (AQL) role brings deep knowledge...disease area and program level including integration within the Quality Management System (QMS), and ensuring individual… more
    Pfizer (03/24/24)
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  • Lead Regulatory Coordinator

    University of Washington (Seattle, WA)
    …Division of Hematology and Oncology has an outstanding opportunity for a full-time Lead Regulatory Coordinator (Research Coordinator (ES 7)). This position is one of ... protocols and translate research needs into appropriate regulatory requirements. The Lead Regulatory Coordinator will integrate information from multiple sources and… more
    University of Washington (03/15/24)
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  • Clinical Oversight Lead II/Senior Clinical…

    United Therapeutics (Durham, NC)
    …include both domestic and international travel. + Develop clinical oversight plans ( Quality Management , Protocol Deviations, Vendor Oversight, etc.) to oversee ... corrective action preventative action (CAPA) and effectiveness checks using Quality Management System technology as appropriate +...the clinical research process, including US FDA, EU, and GCP regulations, and the function of quality more
    United Therapeutics (01/31/24)
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