- 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. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager External Data Management , is accountable for an end-to-end delivery ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...collection of diverse external data types. Advises Study Data Manager on complex vendor management issues and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and sustainability ... of the Global Clinical Data Standards for quality submissions and success of the Daiichi Sankyo R&D pipeline by managing activities associated with standards… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Manager , ERP Applications is accountable for maintaining and modifying assigned ERP ... elements of each enhancement or project.Responsibilities:Responsible for developing high quality solutions based on Functional Design documents. Perform system… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …and compliant execution of all congresses.Responsibilities- Congress Planning and Execution Management - Manage the planning and onsite execution for the global and ... have an impact on the program and organization - Budget Management - Fiscally responsible for establishing, monitoring and managing multimillion congress budgets-… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …team resources, issues, risks as well as achieving overall project level quality metrics. An ideal Associate Director, Program Management must have ... , impact analysis, and resolution of escalated risks/issues by project manager (s)Program budget management including preparing and requesting release of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records for regulatory inspections and internal audits.Ability to utilize multiple electronic quality systems and SAP.Knowledge of cGMP regulations and FDA/EU ... management and continue to develop professionally.Strong proficiency utilizing electronic Quality Systems per curriculum.Utilizes tools within MS Office and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Office Suite, Market Intelligence Tools, Coupa or other eSourcing and contracts management systems Self-starter with a proven track record of delivering ... promoting the utilization of the NNI Procurement Methodology through Category Management and Strategic Sourcing activities. This position will ensure the acquisition… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop ... Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work...will be responsible for all aspects of clinical project management for a trial(s) in our portfolio which includes… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position This position is responsible for the financial management and oversight of internal and external strategic collaborations to optimize… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …He/she supports CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems . You will also write SOPs (Standard ... Asset / Reliability Engineer will be responsible for ensuring equipment/ systems required to support an expanding Cell Therapy facility...and work instructions that are part of the QMS ( Quality Management System).You combine the knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Develops a deep and collaborative relationship with key stakeholders and senior management within Finance, Legal, IT, Quality , Compliance and Product Safety. ... within Novo Nordisk Inc (NNI). The role is responsible for stakeholder management and optimizing stakeholder experience. It collaborates closely with subject matter… more
- Merck & Co. (Rahway, NJ)
- …ensure high quality data and timely and complete synchronization between systems . Acts to resolve all issues and discrepancies as data stewards responsible for ... budget preparation and overall accounting knowledge. Thorough understanding of data manager packages. Strong understanding of Enterprise Process Management to… more
- Eisai, Inc (Nutley, NJ)
- … across Tokyo, US, EMEA, China ALA regions.Degree in Computer Science, Information Systems or Information Systems Management required.Minimum of 10 years' ... Manager (CISM) certification is essential. Additional Certified Information Systems Auditor certification is advantageous.ISO 27001:2013 Lead Implementer /… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and ... team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …searchable and accessible Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.) Works directly with ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are… more
- Ring Container Technologies (Springfield, NJ)
- **Job Purpose** To develop and ensure effective implementation of the plant's quality and food safety management systems in accordance with product ... British Retail Consortium (BRC). **Key Responsibilities and Duties** Maintain a controlled Quality Management System (QMS) consisting of detailed policies and… more
- Mercury Systems (West Caldwell, NJ)
- …methodologies and standards * Knowledgeable of AS9100 standards and continuous improvement of Quality Management Systems * Experience utilizing root cause ... As our Quality Manager , you will help lead...this role is the support and improvement of our Quality Management System and underlying business practices… more
