- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operate PPM systems and processes.- Apply AI tools to automate and improve portfolio data quality .- Onboard new projects and teams to PPM systems.- Assist with ... training modules and support decision-making for global/regional projects Evolve Project Management (PM) Processes: - Contribute to improving project management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.)-Ensure operational study-level timeline, budget, deliverables and quality management -Facilitate escalation and resolution of issues with CRO/ vendors/ ... the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery-Lead...with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical… more
- Merck & Co. (Rahway, NJ)
- …learned.clinicaltrialjobsEligibleforERPRequired Skills: Accountability, Accountability, Adaptability, Clinical Data Management , Clinical Development, Clinical ... quality activities within the assigned therapeutic area.- This includes operational quality management and inspection management activities.The CQOM will… more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of ... maintaining compliance and quality .Must be able to discern the criticality of issues and communicate to management regarding complex issues .Ability to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Process Excellence Specialist III role ... is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …maintaining compliance and quality .Must be able to discern the criticality of issues and to communicate to management regarding complex issues .Ability to ... inspection readiness within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …automation and controls system software, hardware and associated interfaces inclusive of data management , issues , deviations, corrections, remediation and ... will be responsible in handling day-to-day activities inclusive of life cycle management , issues , deviations, corrections, remediation and improvement efforts of… more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance, industry competitiveness and operational excellence Oversight of performance management : Facilitates regularly scheduled call quality calibrations, ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data systems/automation and ... a change agent to promote flexibility, creativity, and accountability.Advanced project management skills, responsiveness to issues , and demonstrated passion for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues , deviations, corrections and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Merck & Co. (Rahway, NJ)
- …ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling and ... (3) years' experience in a functional area, such as Operations, Management , Quality , Technical Operations, Technology, Engineering Preferred Experience and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data ... according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.Perform tasks on time in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment and capital expenditures (CapEx), ensuring alignment with business objectives, quality , compliance, and cost optimization. The role will work closely with ... cross-functional stakeholders including Manufacturing, Facilities, Maintenance, Engineering, Quality , Finance, Supply Chain and Global Procurement to meet site and… more
- Merck & Co. (Rahway, NJ)
- …acumen supporting pre- and post-implementation processes.Proficient in order processing, sales/customer data management , operational management and process ... and end customers.Develop strategic plans to develop or evolve processes/platforms ensuring data reliability/ quality , scalability and business rules to ensure a… more
- Merck & Co. (Rahway, NJ)
- …collaborate closely with team members and partner groups including formulators, engineers, Quality , Safety, and Facilities management to drive overall success ... to ensure compliance with industry regulations.- Able to report any recurring issues or trends to management for further investigation.Cleanroom Environment:… more
- Merck & Co. (Rahway, NJ)
- …Instrument data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software such as Planisware, ... execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, document control, process improvement, process validation and data management .Partners with Operational Excellence to implement ... experience ownings SOPs, change controls, investigations, CAPAs and other quality system actions.Ability to engage all levels of the organization,… more
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
