- 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)
- …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 ... Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory, Quality , Legal, Privacy and Finance. External relationships include Customer Care… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA and ICH regulations and guidelines Expertise in safety databases, call center telephony systems and quality systems Knowledge of NNI supported disease ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....relation to department objectives. Essential Functions Leadership & Oversight Lead and manage the global Case Processing team, fostering… 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)
- …including FDA and ICH regulations and guideline Expertise in safety databases and quality systems Knowledge of NNI supported disease states preferred (eg, ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Review Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case Processing team,… 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 Rare...and evolving business needs Continuously reviews and evaluates the quality of data and new data sources used in… 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)
- …potential suppliers, manage RFI/RFP and term sheet development, and negotiate contracts. Lead cross-functional teams and collaborate with Quality , Legal, CMC, ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role… more
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …achieving process improvements and associated operating efficiencies * Familiarity with Quality systems and compliance expectations across geographies. Able to ... and logistics to support manufacturing operations while partnering with Manufacturing, Quality , Sales, Marketing, and Finance. Leads the monthly S&OP processes… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and ... Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review ... and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and site-specific procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing/Supply Chain environment, strong analytical and advanced ... requirements and disruption to supply.Maintain system planning parameters (eg lot size, lead -time and safety stock levels) within the site ERP.Assist with the… 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
- 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)
- …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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to ... continuous improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates and procedural… 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)
- …and site-specific procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing/Supply Chain environment, strong analytical, advanced Excel ... requirements and disruption to supply.Maintain system planning parameters (eg lot size, lead -time and safety stock levels) within the site ERP.Assist with the… more
