- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production...the planning and execution of internal audits for all quality system areas for the manufacturing site; write audit… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. SUMMARYProvide support to the Global and Regional Quality Leads, External Partner Quality Leads, and Business Partner ... on assigned programs and in close collaboration with R&D Quality team members to ensure that the organization is...a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Manager , Global Medical Affairs Oncology Publications works with GMA Oncology Publications ... LeadSupports execution and delivery of publication projects to ensure high quality and timely delivery of scientific publicationsManage publication activities in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible for the support ... a fast paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Ensures all systems and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment of system upgrades, ... including the scheduling of key activities and communicating of system downtime to appropriate parties. Identify opportunities for automation and reduction of manual processes across the team in conjunction with our Financial Disbursements roadmap.- Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high- quality deliverables, and ... around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and ... Change Management process. Through careful coordination with stakeholders and consistent quality assurance, minimize the risk of changes, strive for uninterrupted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... report, and communicate on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve it. Establish KPIs for… more
- Daiichi Sankyo, Inc. (New York, NY)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product(s), and their approved indications,...as per SOP 805.21,'Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).' Qualifications: Successful candidates will be able… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Manager as part of the Technical Operations team based in Raritan, NJ. ... Role OverviewThe CAR-T Operations Manager is an exempt level position working within Technical...multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input ... to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: Review CRO/vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides ... input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategies and processes to ensure all systems and solutions meet the required quality standards, collaborate with quality assurance teams to ensure that all ... to ensure that deliverables are met according to agreed timelines and quality standards. Lead a team of professionals specializing in intelligent automation,… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing...of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... and methodologies are understood and utilized. Serve as the lead "relationship manager " to proactively deliver strategic sourcing insights, optimal value and best… more
