• Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... raw materials release, and compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions,… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (North Wales, PA)
    Job Description- Role Summary:The Process and Systems Lead Senior Director , Medical Operations (Lead, P&S) is a leadership role within Global Medical and Value ... Medical and Scientific Affairs (GMSA) that reports directly to the Executive Director (ED) Global Medical Operations Lead.-The Lead, P&S is responsible for managing… more
    HireLifeScience (03/22/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …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 ... requirements and evolving needs. Liaise with global and HQ counterparts to promote quality and consistency across regions. Leads the design and implementation of a… more
    HireLifeScience (03/28/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …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 ... resources to CMR stakeholders. Liaise with global and HQ counterparts to promote quality and consistency across regions. Lead the design and implementation of a… more
    HireLifeScience (03/28/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …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 ... to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance. Proactively track, monitor and report trial risks,… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …management responsibility. -The Director - Automation Leader position will report to the Senior Director , Enabling Facilities, and will be a member of the EF ... Job DescriptionPosition Description : Director -Automation Leader (M3)The Enabling Facilities (EF) group...and communicating effectively with partner groups including IT, EHS, Quality , Site facilities and end users.Committed to improving the… more
    HireLifeScience (03/26/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and Data Management members to ensure timely deployment of high- quality biomarkers analysis on clinical samples.ResponsibilitiesOversee implementation of biomarker ... strategy for global clinical development by leading and supervising a group of Translational Biomarker Leads. This responsibility includes working as an individual contributor as a Translational Biomarker Lead for a project if necessary.Facilitate/oversee… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …data review tools including listings, patient profiles and other documents to enhance data quality efforts. He/she will serve as the CS primary point of contact and ... advisor to cross-functional partners for data quality processes, enhancements and workstreams (eg IDRP), including but not limited to Data Management and… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and assessment of changes in relevant healthcare policies and regulations. The Senior Director is accountable for managing, leading, and developing MPAC ... Independent Medical Education grants, Corporate Sponsorships, educational and healthcare Quality Improvement sponsorships, USMA congress sponsorship planning, and monitoring… more
    HireLifeScience (03/05/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... that CMC documentation is complete, well organized, scientifically sound, of a high quality , aligned with the current regulations, and presented in a manner that… more
    HireLifeScience (03/01/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA ... serves as a strategic partner managing quality and regulatory compliancerelated to Good Pharmacovigilance Practices (GVP) and other related activities performed by… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (Millsboro, DE)
    Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... accountable for the full technology stack across all aspects of Operations, Supply, Quality and Business support at the Millsboro site. The Site Digital Technology… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including… more
    HireLifeScience (03/01/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Director , Quality Assurance as part of the Quality team based in ... Raritan, NJ. Role Overview The Director of Quality Operations , CAR-T is...on continuous improvement to organizational agility. Manages team of senior managers and professionals within Quality . Hires… more
    HireLifeScience (01/31/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    Position Summary The Engineering Director is directly responsible for leading the Engineering team in the successful design, construction, and commissioning of ... and effectiveness of the operations and participate as a member of the Senior Management Team in developing site strategies and policies and represent the company… more
    HireLifeScience (03/16/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population and protocol compliance for ... Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before… more
    HireLifeScience (03/21/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …and on the market through appropriate epidemiology studies. This Executive Director , the sub-functional lead for Epidemiology group in Global Medical Safety, ... able to provide essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of high-impact… more
    HireLifeScience (03/07/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... operational planning, start-up, conduct, reporting, and close out) including timeline, quality , and budget management Drives and leads the successful execution of… more
    HireLifeScience (03/09/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …QA at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently ... around rare diseases and immune disorders.Summary Lead the implementation of the quality strategy closely aligned with the business strategy within one or more… more
    HireLifeScience (02/24/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …values that can meet business objectives. Relationships This position reports to Director of Business Applications in Information Technology and directly manages a ... and validation requirements Establish and enforce software source control and quality assurance for Continuous Integration and Continuous Deployment (CI/CD) of all… more
    HireLifeScience (03/06/24)
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