- Legend Biotech USA, Inc. (Raritan, NJ)
- …forms, etc. are printed and available for productionOversee batch records review and completeness of all associated documentation ensuring compliance with written ... Policies and procedures as required for batch releasePerform First Quality review for executed batch records dailyPerform other assigned duties as may be required in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or final product samples submitted to the QC laboratories.Perform peer review /approval of laboratory data.Utilize electronic systems (LIMS) for execution and ... documentation of testing.Create, review and approve relevant QC documents, SOP's and WI's.Perform...constraints and desired outcomes to make effective decisions.Employs good project management principles to appropriately align time, resources, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and gene therapy components and associated manufacturing processes.Provide support in project management, purchasing, shipping, and invoice review for technical ... decisions that drive both supply assurance, cost savings as well as project executions.The individual manages suppliers from contact to contract within a category,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality.Work closely with Sr. Manager, Strategic Initiatives to ... design of facility upgrades to support integration of new technology.Ensure project deliverables are executed in an effective, efficient, and compliant… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various department projects to drive continuous ... lead as a change agent to promote flexibility, creativity, and accountability. Project management skills, responsiveness to issues, and demonstrated passion for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of a large-scale global clinical program using strong clinical project and programmanagement, leadership, decision-making ability, people management, and ... develop a cross-functional, integrated study plan and create initial study budget. Review study feasibility assessments provided by the CRO(s), lead the CRO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various ... and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management Process for the respective business areas.Responsibilities:Leadership and Project Management:Lead the end-to-end quality execution across Medical Affairs ... QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs).… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including project -specific training and coaching of team members and review of team output cross-functionally.Effectively represent the CSPV on the Global ... Safety MD, will lead the development and implementation of integrated project /product risk management strategies aimed at achieving the optimum benefit-risk for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in setting strategies and plans for their teams with the CROs. Responsible to review metrics and issues for their studies and ensure proper attention and mitigations ... the needs of the overall development plan agreed to by the Global Project Team (GPT). People and Resource Management:Develops talent through providing focused career… more
- Genscript USA Inc. (Piscataway, NJ)
- …performance, safety, and compliance requirements. In addition to capital project responsibilities, the Facility Engineer will provide high-level technical oversight ... lead for major capital projects, from design through commissioning. Review and validate design documents, technical specifications, and contractor submittals… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …process, to ensure information is documented and reported timely.Folder Audit includes: Review HCP Engagements that are considered closed according to the policy ... Head a monthly pass/fail report for performance managementMonthly full file audit includes: Review that all documents are uploaded and in the appropriate section of… more
- ENTRUST Solutions Group (Dunellen, NJ)
- **Description** Join ENTRUST Solutions Group as a Substation Project Manager and become a vital part of our dynamic team! In this role, you will lead and execute ... focus will be on maintaining schedule and budget performance, enhancing project profitability, and fostering strong client relationships and satisfaction. Quality… more
- Merck & Co. (Rahway, NJ)
- …main focus will be on document production processes, including content authoring, review and finalization, and feed to the Submissions Assembly team. The Business ... on requirements and design topicsSupport functional areas in identification and review of process questions and issues related to submission content management,… more
- Merck & Co. (Rahway, NJ)
- …activities performed by external partners.Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, ... milestones, and risks within our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.)… more
- Tris Pharma (Monmouth Junction, NJ)
- …and troubleshooting of problems with instrumentation and analytical preparations Meets project deadlines and performance standards, as assigned Compiles with all ... and experience level relative to requirements of the position and a review of related industry standards and internal equity.Additional benefits: In addition to… more
- Merck & Co. (Rahway, NJ)
- …party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make informed ... team accountable to deliver on priorities.Document preparation, maintenance, and review of documentation including specifications, testing protocols, testing reports,… more
- Merck & Co. (Rahway, NJ)
- …into GSVC Annual Product Plans. This includes leading the development, review and communication of GSVC individual content within the V&I ... Enterprise Leadership Responsibilities:Leads projects and solves complex problems: Oversees project management, providing solutions to complex issues, and guides… more
- Merck & Co. (Rahway, NJ)
- …CAPA & Deviation management to ensure timely closure of any observationsAuthor, review , and approve GMP procedures and documentation, with an emphasis on operation's ... Validation, Operational Excellence, Personal Initiative, Process Optimization, Product Testing, Project Team Leadership, Quality Management, Quality Management System Auditing,… more
- Merck & Co. (Rahway, NJ)
- …to ensure timely execution of outsourced GMP testing.Perform data review of laboratory notebooks and analytical reports.Author release specifications, analytical ... associated with GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders. Identify appropriate corrective and… more
