- 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
- 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
- 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise ... records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift operations meetings, the daily wrap up… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and problem solving program to improve safety, compliance, cost, process stability building quality and efficiency into processes to improve lead times and ... cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to support of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management ... The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project...deliverables for MES and/or digital projects and ensures that quality , risk, cost, time are managed within the overall… 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 ... execution.Knowledge of LMS system.Supports the maintenance and reporting of quality training metrics.Support daily manufacturing activities when necessary. RequirementsA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment and capital expenditures (CapEx), ensuring alignment with business objectives, quality , compliance, and cost optimization. The role will work closely with ... cross-functional stakeholders including Manufacturing, Facilities, Maintenance, Engineering, Quality , Finance, Supply Chain and Global Procurement to meet site and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supply Chain team based in Raritan, NJ. Role OverviewThe Site Supply Chain Lead will be part of the Manufacturing Technical Operations team responsible for leading ... will partner with the plant leadership team, various Technical Operations and Quality functions to support both clinical and commercial manufacturing operations, in… 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
- Merck & Co. (Rahway, NJ)
- …Business Systems , Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The… more
- Merck & Co. (Rahway, NJ)
- …research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound knowledge and ... Job DescriptionIn partnership with the Clinical Quality Operations Lead (CQOL and Head...clinical development programs, clinical trial processes as well as quality management systems and quality … 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
- 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
