- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …empowers the content operations team to manage content with high efficiency, quality and speed, and promotes adoption of design standards, improved usability, and ... Enablement role will report directly into the Director, Content Management & Production Lead as part of the broader Experience Operations team under the MPS… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Health Canada. This individual also supports senior staff with required systems and process maintenance. Responsible for supporting the preparation, delivery,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within budget, per direction, and are internally consistent with group deliverable quality Systems and Data Management Responsible for gross-to-net forecast ... customer alignment as necessary. The position is responsible for: Lead support for development of gross-to-net forecasts for Diabetes...and evolving business needs Continuously reviews and evaluates the quality of data and new data sources used in… more
- Integra LifeSciences (Plainsboro, NJ)
- …new treatment pathways to advance patient outcomes and set new standards of care. The ** Lead Quality Inspector** serves as a Lead Associate, Quality ... using electronic document storage. + Minimum of 5+ years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably… 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
- 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
- Genscript USA Inc. (Piscataway, NJ)
- …matter expert (SME) for mechanical, electrical, and plumbing (MEP) systems —particularly HVAC—during major facility construction and expansion projects (230,000+ sq ... is essential. This role offers a rare opportunity to design foundational systems for how we manage equipment and facilities, while also driving in-house… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …sites, internal GMP (Good Manufacturing Practices) departments, external partners, and quality systems for ensuring compliance with regulatory requirements and ... You will be responsible for conducting thorough assessments of potential vendors' quality systems , capabilities, and processes to ensure alignment with… 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)
- …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)
- …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
- Merck & Co. (New York, NY)
- …Team, you will collaborate closely with Account Executives, Integrated Delivery Systems leaders, and other field colleagues to deliver seamless, patient-focused ... health care settings such as physicians' offices, integrated delivery systems , pharmacies, and hospital clinics to effectively execute your responsibilities.Key… 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)
- …Calibrations are scheduled, completed, and properly documented with supporting records attached. Lead the Building and Environment monitoring team to ensure the ... control and update / communicate with all teams with any emergencies and disruptions. Lead the maintenance and metrology support specialists to ensure all vendors for… more
- Genscript USA Inc. (Piscataway, NJ)
- …cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The ... item replenishment to meet inventory KPIs while ensuring continuity of supply. Lead strategic sourcing and manage the procurement process for direct materials and… 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
- 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 ... executionKnowledge of LMS systemSupports the maintenance and reporting of quality training metricsSupport daily manufacturing activities when necessaryRequirementsA minimum… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …various Technical Operations groups [e.g., Operations, MS&T, Supply Chain, etc.] and Quality functions to lead all planning and detailed scheduling activities ... efficient scheduling of equipment PMs & Cals while supporting manufacturing plan. Lead material allocation improvements and other optimization projects.An ability to… more