• Merck & Co. (Rahway, NJ)
    …with external suppliers as assigned.Understand and apply regulatory / compliance requirements relative to design controls and risk management ... Senior Scientist - Development Strategy, Design Controls and Risk ManagementOur company's Device Development (DD) Team designs, develops, and commercializes… more
    HireLifeScience (03/21/24)
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  • Merck & Co. (Rahway, NJ)
    …and other applicable worldwide regulations and our Company procedures. - The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs and ... Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations - API,...Ensure all API (including new modalities) are manufactured in compliance with cGMP and regulatory filings. Perform… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... interests from the world's biomedical literature in support of regulatory , clinical research, marketing, and legal functions.- Plans, organizes, monitors,… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must actively… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …Rahway site. Integrates EHS programs into daily operations to assure regulatory compliance , achieves continuous performance improvement, meeting EHS performance ... strategies to manage identified risks.-Completes industrial hygiene and biosafety hazard/ risk assessments, ergonomic evaluations, process hazard analysis, and incident… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The incumbent is responsible for… more
    HireLifeScience (03/26/24)
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  • Catalent (San Diego, CA)
    …Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma in San...include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and coordination of… more
    HireLifeScience (02/14/24)
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  • Merck & Co. (Rahway, NJ)
    …changes and developments align with business requirements, industry standards, and regulatory compliance .Define and enforce change control processes and ... needs and align SAP solutions accordingly.Act as a trusted advisor to senior management, providing insights and recommendations on leveraging SAP capabilities to… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionPosition Description: Senior Fermentation Operations Technician (Days) This position is in direct support of our Upstream Fermentation manufacturing ... Tangential Flow Filtration, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you will be an energetic leader with strong interpersonal,… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (Rahway, NJ)
    …will contribute to equipment and facility design, system commissioning/ qualification, regulatory certification, as well as other workstreams' critical activities to ... management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and process needs… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Durham, NC)
    Job DescriptionPosition Description: Senior Technician, Maintenance The Senior Maintenance Technician is responsible for providing equipment troubleshooting and ... Quality, Automation, Technology, and other groups as required.-The Lab Senior Maintenance Technician will provide maintenance supporting vaccine process equipment… more
    HireLifeScience (02/28/24)
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  • Merck & Co. (Durham, NC)
    …operable.Responsible for performing assignments in conformance with appropriate Regulatory (GMP's) and department Standard Operating Procedures which assure ... maintenance (PM) plans/calibration procedures, task lists, etc., as required.Work compliance systems for maintaining PM program and assessing equipment -… more
    HireLifeScience (02/28/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ICH guidelines, etc.ResponsibilitiesAdditional representative ... other activities, as necessary.Participates and helps maintain study operations planning, risk assessment and mitigation strategies, and reviews and helps ensure… more
    HireLifeScience (02/16/24)
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  • Catalent (Harman, WV)
    …and administers the Risk management system and track completion of risk assessmentsCompile pertinent QA metrics for Senior Management reviewAssemble critical ... evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards The Candidate… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …activities and fosters a culture that seeks to constantly enhance global regulatory compliance for aggregate reports.Develops quality systems, tools, and ... procedures for the aggregate report activities to assure regulatory compliance and meet regulatory reporting timelines.Controls and assures the quality of… more
    HireLifeScience (03/15/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …and make the appropriate changes to ensure trial conduct is completed in compliance and meets Novo Nordisk's business standards Risk Management: Assessing and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial risks, progress/performance,… more
    HireLifeScience (03/27/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …during regulatory agency inspections and vendor audits.Ensure that a risk -based audit plan is developed, designed and implemented, and that the activities ... lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …in-built controls in relevant process steps to ensure adherence to regulatory compliance .Monitor effectiveness of implementation of applicable clinical ... of R&D QA. Within assigned GPTs, facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and… more
    HireLifeScience (02/24/24)
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  • Merck & Co. (Millsboro, DE)
    …to our Company guidelinesBrings together the right stakeholders to ensure compliance and sustainability of IT/OT solutionsParticipate in regulatory audits ... maintained, and that all operational activities are compliant with regulatory , safety, cyber-security, business continuity and financial requirementsLeadership of… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …development and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing ... as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to… more
    HireLifeScience (03/01/24)
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