- Eisai, Inc (Nutley, NJ)
- …process.Team Leadership: Lead the global teams in the execution of Risk and Compliance initiatives and support professional growth. Risk Management: ... define, implement and ensure (govern) appropriate controls.Develop strategies to manage compliance risk across IT portfolio.Communicate with IT business… more
- Merck & Co. (Rahway, NJ)
- …and future state business objectives. Within the EIT SAP Platform Team, the EIT SAP Technology Lead will assume the crucial role of leading all areas of SAP ... SAP Middleware/Integration and Reporting/Analytics standards, patterns, and technologies.- They will lead the Technology Integration Meeting and provide Senior … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, NJ. ... developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor...Role OverviewThe Quality Compliance - Lead Auditor CAR-T is responsible for… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company's Device Development and Technology (DD&T) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled ... strategic direction on the company's highest complexity programs they are selected lead to ensure high quality products and robust manufacturing processes.-- This… more
- Merck & Co. (Rahway, NJ)
- …and technology portfolio and information governance programs; and design and lead technology -related solutions to further the strategic goals of the ... audit and data integrity reports to identify, investigate and resolve anomaliesEnsure compliance with all corporate and departmental IT risk management policies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... disorders. Summary The Oncology Early Development Center (OEDC) Program Lead , who directly reports to the Head of the...acts as a "change agent" within DS to ensure compliance and alignment with DS highest standards. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Merck & Co. (North Wales, PA)
- …our Manufacturing Division focuses on late-stage drug substance process development, technology transfer, and in-line support for vaccines and biologics.-We seek a ... in support of the following: process performance qualification (PPQ), risk assessment, control strategy, process comparability reports, and/or regulatory… more
- Merck & Co. (Rahway, NJ)
- …space, including process flow diagrams and engineering drawingsProcess development and technology transfer experience including the use of risk assessment ... (SPD) team. The successful candidate will be expected to lead the team focused on the design of new...as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders… more
- Merck & Co. (Rahway, NJ)
- …space, including process flow diagrams & engineering drawingsProcess development and technology transfer experience including the use of risk assessment ... Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and… more
- Merck & Co. (Rahway, NJ)
- …Associate Director, IT SOX Program Manager plays a key role within the IT Risk & Compliance Programs function. Responsible for the end-to-end oversight of the ... Job DescriptionOur company's Information Technology division partners with colleagues from across the...and execution for one of our company's most critical compliance programs. The individual partners cross-functionally with divisions across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …EMA, Swiss medic, and other local authorities as necessary to address compliance relevant matters and lead any remediation efforts. ResponsibilitiesLeads ... of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise...Audit and Compliance QA function to develop compliance and risk criteria, in order to… more
- Merck & Co. (Rahway, NJ)
- … risk posture. Define the requirements, best practices, and lead the collaborative development of cloud system/service architecture, design, and engineering. ... development, engineering, and deployment of security controls used to protect. Ensure compliance with all requirements applied to cloud services and technology .… more
- Merck & Co. (North Wales, PA)
- …products including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, and review of ... sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and… more
- Merck & Co. (Rahway, NJ)
- …process modeling, and data analysisExperience with chemical engineering-related technology developmentExperience with risk assessments, process characterization, ... leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and ... to close nonconformance records and identify necessary corrections.Key Responsibilities Lead cross functional investigations independently from end to end. Ensure… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team that will build biopharmaceutics ... policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... as identified by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor for the commercial business and operations supporting US… more
- Tris Pharma (Monmouth Junction, NJ)
- …spanning neuroscience and other therapeutic categories employing our proprietary science and technology . Our science and technology make us unique, but it ... incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …unmet medical needs of people globally by leveraging our world-class science and technology . With more than 100 years of scientific expertise and a presence in ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research,… more
