- 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
- Insmed Incorporated (San Diego, CA)
- …and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems . Identify improvement opportunities and ... inspections, working with regulators, and vendor/supplier audits.Broad knowledge of risk-based quality systems approaches consistent with ICH Q10 for… more
- Merck & Co. (Durham, NC)
- …aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor support in the execution ... monitoring data. Perform review of process simulation batch records. Perform Quality retain sample management activities, if applicable. Lead Shopfloor… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Customer Data Management (CDM) system as well as other MDM systems within the team (Product, Patient). This role will function as liaison with stakeholders ... Master Data policies, procedures, and Novo Nordisk Way of Management Manages all quality initiatives that come...regarding the Master Data Domain Works closely with Sr. Manager - Data Management Operations to support,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work ... and updates Study Supply Plans in close communication with CSO project Management Lead.Responsible for the Clinical Label Development process which includes creation… more
- Aequor (West Chester, PA)
- …in Presentation skills (presenting Dashboards, etc). o 5&plus years of project management experience. o 5&plus years of experience in strategic operations or ... healthcare landscape. o Experience in developing and optimizing processes and systems for large-scale, cross-functional teams. Screenings: 1. Basic Background 2.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the ownership and management of these processes for GxP and Non-GxP systems and services. In this position, the GSM will lead major incident calls, conduct ... rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is...problem management meetings, and drive process and policy adaptation within… more
- Genmab (Plainsboro, NJ)
- …the HR Data Manager to promote data governance and enhance data quality and insights, and providing HR Reporting and Analytics to key stakeholders, including HR ... is essential to fulfilling our purpose.Join Our Team as a Workday Reporting Manager ! We are excited to invite applications for the position of Workday Reporting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …at the sitePerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Require minimal direction to complete tasks, ... multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team... for decisions outside established processes.Routinely recognize and resolve quality issues or data trends. Seek management … 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 ... myeloma.Legend Biotech is seeking a QA Batch Warehouse Associate Manager as part of the Quality team... and continue to develop professionally.Strong proficiency utilizing electronic Quality Systems per curriculum.Utilizes tools within MS… more
- Merck & Co. (Durham, NC)
- …Floor QA proceed in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, ... investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (eg, CLUE and SAP).Support and maintain a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … management tools Strong hands-on knowledge of Content Management Systems related platforms (specifically, Adobe Experience Manager , Adobe Assets, Adobe ... Workfront Strong understanding of digital content production, workflows,and supply chain management Familiarity with content management systems (CMS)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and ... Management process. Maintaining, adapting and monitoring a comprehensive change management process for IT systems and services. Coordination monitoring of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … systems /tools (eg, Veeva, Salesforce, Sharepoint) Understanding of data management , data storage and data governance Demonstrated engagement to enhance technical ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....ready to make a difference? The Position The Senior Manager of Medical Information Operations Excellence supports development, maintenance… more
- Aequor (West Greenwich, RI)
- …schedule and be available at the committed times. Ideal candidate: Supply Chain Manager (Level 5) with strong expertise in SAP Bills of Materials (BOMs), ... a critical role in managing SAP BOMs, procurement functions, and data quality while supporting cross-functional teams. The ideal candidate will have 5&plus years… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processing of requests and delivery of periodic review reconciliation reports Project Management : Manage all quality deliverables for the timely processing of ... around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of...Administration is a member of the Biostatistics and Data Management Data Operations team and serves both as a… more
- Novo Nordisk Inc. (Dallas, TX)
- …need them most, by creating an environment where innovation and chronic disease management drive optimal health outcomes. Are you ready to realize your potential? ... makers, including but not limited to: Payers/Regional PBMs, Health Systems with aligned Payers, Municipalities, Coalitions, Specialty Pharmacy, Federal Agencies… 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 ... We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work...will be responsible for all aspects of clinical trial management including execution of clinical trials from protocol finalization… more
- Merck & Co. (Rahway, NJ)
- …compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead and/or ... Experience in one or more functional areas such as quality assurance, laboratory, manufacturing, production, equipment/facilities management , regulatory.… 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
