- Merck & Co. (Rahway, NJ)
- …Clinical Safety for business process management and continuous improvement.-Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable ... Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & Clinical… more
- Tris Pharma (Monmouth Junction, NJ)
- …Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality Management Systems (QMS) supports, oversees ... and Drug Administration (FDA) standards and batch record specifications.The incumbent uses systems thinking and a holistic systems -based approach to drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for CDO & Novo Nordisk (eg Investigators and site staff, Health Systems , Contract Research Organizations and Site Management Organizations etc.) Establish and manage ... development opportunities to enhance skills and knowledge Budgeting and Cost Control : Plan operational budgets, monitor expenses, and implement cost-saving measures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diseases and immune disorders. Summary Deliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS) ... standard methodology. Oversee applications support groups' system validation and change control process. Collaborate with the Services organization to ensure smooth… more
- Merck & Co. (Durham, NC)
- …System.Provide guidance to staff for the implementation, management, and enhancement of document control systems on the global and local level and ensure ... with Change Management and GMP Documentation Management is required.Electronic document control systems experience is highly desirable.Understanding of the FDA… more
- Aequor (Libertyville, IL)
- …budget. Follow change control process.Portfolio Financial and Reporting: Support Site IT lead and Global IT PMO lead on tracking and managing portfolio ... (network, storage, server, cyber, cloud).Must have GMP and computer systems validation experience in pharmaceutical manufacturing.5&plus years of end-to-end project… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Electrical work Ability to develop new systems and reverse engineer existing systems Lead external contractors for project execution Manage a project from ... operation and troubleshooting PPCL Programing experience is preferred Understanding Supervisory Control & Data Acquisition Systems (SCADA) Electrical systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and change management initiatives.Also responsible for expense or headcount control procedures and management reporting capabilities.Develops and maintains a working ... - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase...are always maintained and accurate.Accountable to the Global Team Lead (GTL) and GPT (Global Project Team) for the… more
- Aequor (Newbury Park, CA)
- …contract, and the other two will be 12-month contracts Ideal candidate: Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, ... and GCP regulations. Validation and change control experience is required. Strong documentation, operational, and guideline compliance experience. No specific degree… more
- Aequor (South San Francisco, CA)
- …Early Clinical Development (ECD) department is to optimize the support of clinical systems to provide high-quality clinical trial data insights and to offer data ... integrated Quality Risk Management Plan (iQRMP) and associated risk mitigation and control strategies, provide processes and tools for oversight of the overall risk… more
- Merck & Co. (Rahway, NJ)
- …manufacturing execution systems , quality & labs systems , resource planning systems , MES and Process Control technologies, track & trace, cold chain and ... with the Enterprise Architecture team, is responsible for delivering business, systems , information and technology architecture artifacts that drive investments for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and timely assessments associated with change control activities Ensures change control activities for systems are completed in a manner in compliance ... a commercial biologics manufacturing facility and this role will assist with manufacturing systems and equipment onsite. This is an onsite based role with relocation… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …priorities, forecasting, and identifying resources needed to make improvement to existing systems as needed. This role is the site Subject Matter Expert (SME) ... for site GMP Clean Utilities infrastructure and systems (WFI, Clean Steam, Pharmaceutical/Oil-Free Compressed Air, Process Gases, HVAC, etc.) and applications in… more
- Merck & Co. (Baton Rouge, LA)
- …coordination leadership and implementation of troubleshooting activities and change control .Initiate and lead collaboration within the Operations, Quality ... with senior leadership. SPECIFIC RESPONSIBILITIES: Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and… more
- Aequor (Framingham, MA)
- …framework. Proficient in process data analytics Knowledge of computerized systems in biopharmaceutical manufacturing environment, ie, Distributed Control ... Manufacturing Science ensures manufacturing processes are capable, compliant, in control , cost effective, and continuously improved. Provide collocated technical… more
- Merck & Co. (Durham, NC)
- …using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems and electronic batch record systems . Experience ... requires strong leadership, technical writing, and problem-solving skills.- You will lead and/or support critical project initiatives at the site, support the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according… more
- Merck & Co. (Millsboro, DE)
- …state regulatory requirements for animal welfare, management of controlled substances, quality control testing according to GMP standards, and emissions control ... officer on the Institutional Animal Care and Use Committee (IACUC). Lead numerous projects including process improvement and safety initiatives.Coordinate / oversee… more
- Christus Health (Tyler, TX)
- …optimize their assigned applications in a timely and high-quality manner. The Systems Analyst Senior will provide application support and optimization. They work ... software. This position must possess sufficient detailed healthcare knowledge and systems expertise to implement medium to high complexity assigned application with… more
- Christus Health (Irving, TX)
- …optimize their assigned applications in a timely and high-quality manner. The Systems Analyst I will provide application support and optimization. They work closely ... software. This position must possess sufficient detailed healthcare knowledge and systems expertise to implement medium to high complexity assigned application with… more
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