- embecta (Parsippany, NJ)
- …focus on financial integrity, operational efficiency, regulatory compliance, and enterprise risk management . As a senior leader in a highly regulated industry, the ... collaboration with senior leaders across Finance, Legal, Compliance, IT, Quality , and Operations to proactively identify risks, recommend actionable solutions,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to ... standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implementing study/program-specific quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA ... Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial...stakeholders and CROs to ensure high data quality , proactively identifying and resolving issues throughout… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management :Develops talent through providing focused career development, performance management and manages retention.Fosters a high- quality culture ensuring ... immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program(s). Provides managerial oversight to colleagues… more
- 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
- Merck & Co. (Rahway, NJ)
- …Technical Support and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program:ResponsibilitiesPerform ... oversee both internal and external auditing and Animal Health Supplier Quality Management .- Required QualificationsBachelor's degree (a degree in Engineering,… more
- Merck & Co. (Rahway, NJ)
- …work with area to ensure resolution of audit findings. Notifies relevant management of unresolved issues /trends.-Specific and/or additional duties may include, ... quality and our company's standards and communicate project status to management .Act as Development Quality representative for in-house or outsourced… more
- Merck & Co. (Rahway, NJ)
- …final versions and - congress QR code process. Assist with reference requests, bibliography management , posting of study data - packages for author access and ... and written communication Ability to know when and how to appropriately raise issues to team and to management Ability to communicate complex medical/scientific… 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …quantitative systems pharmacology, model-based drug development (MBDD), or scientific data management .- Proven experience leading cross-functional teams to ... Sciences, Process Leadership, Product Management , Rapid Prototyping, Risk Management Framework, Scientific Data Management , Scientific Software… more
- Capital One (New York, NY)
- …audits of controls in cloud-based environments 4+ years of experience in risk and data management 4+ years of experience performing data analysis in ... microservices), information security (application security, network security, cyber security, data protection), information systems risk management , information… 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)
- …of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data , developing and ... of multiple myeloma.Legend Biotech is seeking Supervisor, QC Micro as part of the Quality team based in Raritan, NJ. Role OverviewThe Supervisor, QC Micro is an… more
- Merck & Co. (Rahway, NJ)
- …Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Studies, Clinical Testing, Clinical Trials, Data ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… 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)
- …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)
- …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
