- Merck & Co. (Rahway, NJ)
- …Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: Monitor user ... Experience and Skills:Candidate must be familiar with IT system and business process support , preferably in the Regulatory or Labeling Management space with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory requirementsCoordinate with broader DS quality teams to support GRA meeting company policies for quality management (eg, completing ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of...include new ways of working with existing or new systems (eg, Vault RIM)Work with GRA stakeholders to define… more
- Merck & Co. (Rahway, NJ)
- …infrastructure at the Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental ... People Leadership, Plant Maintenance, Preventative Maintenance Programs, Process Control Systems , Project Management, Regulatory Compliance, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work. - Preferred Experience and Skills: ... is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API manufacture, testing, release,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of the Daiichi Sankyo's GxP group.Together with regional management teams plans, will support , conducts and reports internal systems and process audits across ... and internal stakeholders to execute audits effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits,… more
- BioAgilytix (Durham, NC)
- …rather than days. Over time, the same foundation you build will support dashboards, predictive analytics, and other data-driven tools that boost lab productivity ... and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with… more
- Twist BioScience (South San Francisco, CA)
- …influence stakeholders at all levels and effectively communicate complex technical and regulatory concepts.Ability to travel as required to support global ... of our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align with our… more
- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... validation, and design control and risk management techniques to positively support and influence clinical and commercial combination product development and… more
- Insmed Incorporated (San Diego, CA)
- …provides support and promotes collaboration internally to ensure all systems , processes and their outcomes comply with applicable international and national ... and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working with groups to provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor ... instrumentation, automation PLCs, VFDs and electrical practicesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, OSHA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and Skills:cGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg EPA, ... in Raritan, NJ. Role OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy… more
- Insmed Incorporated (San Diego, CA)
- …development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... team to take care of the operational aspects of analytical testing to support process development to enable rapid development of upstream, downstream and formulation… more
- Aequor (Athens, GA)
- …management systems and migration of records from legacy systems . Electronic Document Management (controlled documents, regulatory submission documents): ... support site users in workflow configuration. Provide routine user support . Electronic Document Management (controlled documents, regulatory submission… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and ... will be responsible for overseeing the production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and facility ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Merck & Co. (Rahway, NJ)
- …critical role in driving member satisfaction, improving efficiencies, and ensuring regulatory compliance while advancing the credit union's payments strategy in ... with overall business goals and member needs.Monitor industry trends, emerging technologies, and regulatory changes to keep the credit union on the cutting edge of… more
- Aequor (Thousand Oaks, CA)
- …as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems , and Digital team at ATO B20. The NPI Lead is expected to ... of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills.… more
- Merck & Co. (North Wales, PA)
- …the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Eisai, Inc (Raleigh, NC)
- …applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to detail and ability to ... is responsible for executing core quality assurance functions, supporting regulatory inspections, and collaborating with internal and external stakeholders to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …enhance consumer interactions, and making recommendations for execution improvements Health Systems Strategy Support Collaborate with medical affairs and market ... finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management Develop and...access teams to support the execution of health systems strategies… more
