- 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)
- …to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations ... with study strategy; reviews emerging clinical data regularly; performs quality assessment of Tables/Listings/Graphs before database lock; collaborates with lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality ... and supporting complaint and recall programs. This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as Contract… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the Biostatistics and ... and maintaining new SOPs, Work instructions, templates, and other quality documents.Responsibilities:Leadership, Direction, and Strategy: Establish and manage accountability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …global markets are also met.Cross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the ... dealing with contract manufacturing organizationsMust have solid understanding of quality management and continuous process improvement principles including global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors colleagues on the outsourcing process and procedures. (not ... a formal people manager ). Develops detailed bid analysis for the RD functional group's review. Development and management of other ad hoc special projects as they… 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)
- …label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance ... to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.Vendor Management -supports Person… 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)
- …across organizational lines to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position is also responsible for ... and have an in depth understanding of project strategies/plans.As a staff manager , responsible for coaching PMs on project-related issues including review of their… 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
- Tris Pharma (Monmouth Junction, NJ)
- …knowledge or skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug-device combination ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance ... Manager role is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position will be responsible ... individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Accounting at Novo Nordisk Inc. As part of the NNI Finance team, the manager will business partner with budget controllers (FP&A) and other key stakeholders across ... what it takes mindset and positive attitude Commitment to Quality - dedicated to providing the highest quality... Quality - dedicated to providing the highest quality services to internal and external customers; demonstrates attention… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring that all stakeholders are aligned and informed. Ultimately, the Content Project Manager plays a critical role in delivering high- quality digital content ... A WEEK, IN OFFICE IS REQUIRED The Position The purpose of the Content Project Manager role is to oversee and manage the execution of content projects from strategy… more
