- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Bayer (Whippany, NJ)
- …difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports ... teams to be accountable for the delivery of high quality , ethical standards of service. The role combines digital...of this role, Senior Director, Digital Governance & LMR Lead , are to: Oversight of External Communication Procedure: Acts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and establish transition activities and responsibilities for Legend.Key ResponsibilitiesServes as the Quality Lead in support of cell therapy manufacturing and ... team based in Raritan, NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities...exceptional team to manage the Quality functions ( Quality Assurance, Quality Systems , … more
- Merck & Co. (Rahway, NJ)
- …of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area. Strong knowledge ... Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team,...device risk management activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires… more
- Merck & Co. (Rahway, NJ)
- …Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems , Medical Device Regulations, Medical Devices, Medical ... medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.--… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OOS monitoring and trending program)Contribute to developing and/or improvements to quality systems in support of global implementation of changes ... initiatives.Experience in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE, the Director, Global Distribution Engineering and Technology,...for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics… more
- Formation Bio (New York, NY)
- …them for regulatory inspections. Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Packaging Procurement Director is responsible to lead the Packaging Center of Excellence (COE) organization. The scope for this role ... Annual spend in this category is more than ~$200M, and delivery of high- quality procurement performance and capabilities is expected as part of our Company's global… more
- ValSource, Inc. (Rahway, NJ)
- …projects directly at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves ... currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting… more
- Merck & Co. (Rahway, NJ)
- …for new data assets, partnership opportunities (publishers, payers, health systems , technology vendors), and emerging commercial data technologies.Oversee US data ... gaps versus the ideal state, prioritizing gaps and building execution plans. Lead acquisition of new external assets, formation of partnerships to co-create… more
- Merck & Co. (Rahway, NJ)
- …initiatives. You'll reduce manual reporting through automation, improve decision speed and quality , and help the team adopt data-driven ways of working, translating ... insights into realized savings.-What you'll do: Lead feasibility analysis for automation and analytics opportunities-frame the business problem, quantify potential… more
- Merck & Co. (Rahway, NJ)
- …area ensuring manufacturing activities are not delayed.-- Provide engineering and quality engineering (QE) support, ensuring facilities, utilities and equipment are ... plans and annual reports supporting equipment, critical utilities, and computer systems .- - Demonstrate knowledge of equipment operation to support troubleshooting,… more
- Merck & Co. (Rahway, NJ)
- …interfacing with the automation system assets spanning production, utility systems and associated infrastructure.- Responsibilities of the Operations Specialist ... engineers & chemists, compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies. Once the MACS Center is… more
- Merck & Co. (Rahway, NJ)
- …role involves leveraging your expertise in packaging, particularly in thermal protection systems and in distribution testing. We value the application of sound ... with experienced supervisors who provide valuable guidance while you lead projects from conception to implementation.Primary responsibilitiesLead the development and… more
- Merck & Co. (Rahway, NJ)
- …SOPs for all GxP automation systems . Lead integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere to CFR, ... improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP- Lead automation related investigations into… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… more
- Merck & Co. (Rahway, NJ)
- …Learning (ML), Machine Troubleshooting, Manufacturing Processes, Manufacturing Quality Control, Packaging, Pharmaceutical Process Development, Pharmaceutical ... and ensure raw materials are ordered and available for manufacturing activities Lead data management activities related to communication through FLEx Scheduling and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ensures that the manufacturing building, relevant campus infrastructure, equipment, and systems support business goals and comply with safety, regulatory, and ... response to unexpected issues are critical for this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data … more
