• Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems , including ... investigation/deviation management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling,… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (North Wales, PA)
    …to assess effectiveness-Partners with the Quality & Standards team and Compliance to enable compliant processes and systems and appropriately manage risk. ... Job Description- Role Summary:The Process and Systems Lead Senior Director , Medical Operations...in the organization toward principle-based global processes and a quality systems mindset for key activities. Enables… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …interpersonal and conflict resolution, and oral/written communication skills.Strong background in Quality Systems , with ability to develop/manage a suite of ... Job DescriptionPosition Description : Director -Automation Leader (M3)The Enabling Facilities (EF) group within the Chemical Engineering Research & Development… more
    HireLifeScience (03/26/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …as well as reviewing and tracking CAPAs.Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices ... as well as reviewing and tracking CAPAs.Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …sites to ensure all trial deliverables are met according to timelines, budget, quality standards and in compliance . Proactively track, monitor and report trial ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....& Novo Nordisk (eg Investigators and site staff, Health Systems , Contract Research Organizations and Site Management Organizations etc.)… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …and awareness of the latest technology in information storage and retrieval systems .The Director works cross-functionally and uses experiences to assess the ... Job DescriptionPosition Description: Director , Clinical Literature MonitoringThe Director is responsible for the management and oversight of the day-to-day… more
    HireLifeScience (03/22/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    Quality . Hires and develops employees within the department. Coordinates quality systems related activities among impacted individuals, departments, sites ... the treatment of multiple myeloma. Legend Biotech is seeking Director , Quality Assurance as part of the...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements. Other duties… more
    HireLifeScience (01/31/24)
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  • Merck & Co. (Rahway, NJ)
    Job DescriptionAs a member of the Medical Device Combination Products Quality QMS group, the Associate Director , will participate in and/or lead various ... capabilities that touch every aspect of our business processes, systems , and data. - The Associate Director ...each MDCP Program (with target dates) for execution. Leads Quality / Compliance Risk Assessments including Quality more
    HireLifeScience (03/16/24)
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  • Merck & Co. (Millsboro, DE)
    …and trace, and other global regulatory requirements that impact IT and OT systems in Manufacturing, Quality and Supply ChainKnowledge and Awareness of Industry ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site...full technology stack across all aspects of Operations, Supply, Quality and Business support at the Millsboro site. The… more
    HireLifeScience (03/22/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    … Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key ... Quality Indicators (KQIs). Identify appropriate continuous improvement initiatives for quality and compliance related areas. Deputize for the Head of RD QA at… more
    HireLifeScience (02/24/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    Quality metrics Focusing on mentoring, process excellence, and executionSustain Quality Systems to ensure no critical complaints or regulatory actionsProvide ... Position Summary The Director of Quality Operations provides direct...to oversee all quality aspects within the Quality Assurance Unit ensuring compliance with federal… more
    HireLifeScience (02/08/24)
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  • Exela Pharma Sciences, LLC (Lenoir, NC)
    …Practices (GEP), Good Automated Manufacturing Practices (GAMP) etc.Ability to evaluate automation systems from a compliance perspective and ensure adherence to ... Position Summary The Engineering Director is directly responsible for leading the Engineering...in the successful design, construction, and commissioning of facility systems , as well as all process and laboratory equipment.… more
    HireLifeScience (03/16/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …Patient Support Program and the reason we are seeking top talent for the role of Director , Case Management. Patients are the core of what we do here at Insmed, and ... If so, we want to hear from you! As Director of Case Management, you will be a key...while preparing for new launch products through team and systems expansions. This position reports to the Head of… more
    HireLifeScience (03/12/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …evaluates IT systems risks and vulnerabilities Applies expert knowledge of compliance with all security, regulatory and quality policies and procedures ... values that can meet business objectives. Relationships This position reports to Director of Business Applications in Information Technology and directly manages a… more
    HireLifeScience (03/06/24)
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  • Eisai, Inc (NJ)
    …and compliance with global and regional processes.Ensure contract tracking systems and databases updated with relevant information by the Outsourcing team in ... want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support...providers for Eisai's R&D functions. This role will ensure compliance with key processes and manage the outsourcing team.… more
    HireLifeScience (02/01/24)
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  • Merck & Co. (Rahway, NJ)
    …Sourcing Partners.Ensure appropriate and consistent application of SOPs, standards and quality and compliance measures.Engage with cross functional stakeholders ... statistical programming deliverables using global and TA standards and according to quality , compliance and timeliness requirements; expertise in SAS and… more
    HireLifeScience (02/21/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …to successfully complete implementation plans targeted to improve data model and data flow quality Support all aspects for applicable systems related to UI, data ... quality outcomes Author documentation, review deliverables and ensure compliance to documentation standards Provide resolutions for system failures, research… more
    HireLifeScience (02/03/24)
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  • Novo Nordisk Inc. (Boulder, CO)
    …& other validation activities Review & approve validation procedures, specifications & quality documents for accuracy & compliance Presentation & support for ... discipline experience in pharmaceutical or medical device industry required Experience in quality concepts including technical & compliance review of validation… more
    HireLifeScience (03/23/24)
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  • Merck & Co. (Rahway, NJ)
    …technical mentorship.Experience with Potent Compound processing and containment systems (eg, isolators).Experience with Quality systemsExperience interacting ... responsibility. The Senior Specialist - Process/Facility Engineering position will report to the Director , Engineering and will be a member of the EF Team at the… more
    HireLifeScience (03/24/24)
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  • Merck & Co. (Durham, NC)
    …/ automation issues to improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. ... embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for… more
    HireLifeScience (03/22/24)
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