- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager ... and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to... principles in the design (and resolution) of key quality management system elements to ensure complianceTracks… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product ... pharmaceutical dosage forms preferred4 or More Years Solid understanding of quality management and continuous process improvement principles preferred… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …allow access to unapproved medicines for patients with unmet medical needs.- Quality Management and Continuous Improvement: Provide guidance to teams during ... research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …lock.Ensure DS internal tracking systems are updated (eg Global Project Management System, GPMS). CRO and Quality Oversight: Responsible for management ... set forth by the Study team. The Clinical Study Manager role is primarily a tactical study delivery role,...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data Programmer is a member of the ... Biostatistics and Data Management team and performs programming tasks, including SDTM and...collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of ... Daiichi Sankyo's existing feasibility related portfolio of platforms, tools and systems . Qualifications: Successful candidates will be able to meet the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain effective ... DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review issues log, develop risk mitigations strategies and ensure all systems are operating well as designed. Ensures compliance with internal controls ... of all Financial Disbursements technology applications and other linked systems . Translates business / functional goals into appropriate Financial Disbursements… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …EU preferred)2 or more years Familiarity with pharma and regulatory information management systems (RIMS); Veeva Vault experience preferred. Travel Ability to ... rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global...quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the project.Accountable for the accuracy of project status in the project management information systems , for preparing scope change proposals and stage gate ... to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position...proposals for formal presentation to senior management . Can step in, as needed, on behalf of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and ... Relationship Management - Leads contract related communication with vendors. Respond...spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces for Millennials™ lists.OverviewThis position is responsible for supply chain management and purchase of raw materials, components and services consistent ... with specified levels of quality , delivery, price and total cost. This position will support the Associate Director, Supply Chain & Logistics in managing a network… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …within a cGMP manufacturing environment Advanced proficiency in the use of ERP systems , Warehouse Management Systems , and analytics Ability to promote ... the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role Overview… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team based in ... This individual will be responsible for all technical and program management scope to drive activities ranging from strategic/business plans to managing… more
- Merck & Co. (Rahway, NJ)
- …of the SDLC, excellent communication and collaboration skills, and a focus on quality and customer satisfaction.The Release Manager is responsible for the ... business objectives.The SAP Platform team has an opening for a Release Manager with experience in coordinating and managing releases, knowledge of relevant tools,… more
- Eisai, Inc (Nutley, NJ)
- …5 years of enterprise-level governance and management .Certified Information System Manager (CISM), Certified in Risk and Information Systems Control (CRISC), ... College diploma or university degree in computer science, information science, management information systems , or business administration.Advanced Degree, such… more
- Merck & Co. (Rahway, NJ)
- …Facilitate equipment/system change controls, execute periodic reviews and support Quality Management System (QMS) activities.-Provide technical expertise, ... systems (administration and execution) as well as Computerized Maintenance and Management Systems (CMMS). Knowledge and experience of sterile drug product… more
- Merck & Co. (Rahway, NJ)
- …of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses on the planning, execution and ... of Protocol and related study materials (eg, ICF documents/amendments, data management deliverables). - May interact with internal and external stakeholders (eg,… more
