- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team ... based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T… more
- Daiichi Sankyo, Inc. (New York, NY)
- …centered around rare diseases and immune disorders. Summary: The Oncology Territory Manager represents Daiichi Sankyo to assigned customers. The Oncology Territory ... Manager represents the assigned product(s), and their approved indications,...as per SOP 805.21,'Reporting Adverse Events (AEs) and Product Quality Complaints (PQCs).' Qualifications: Successful candidates will be able… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality ... strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Monitoring Oversight Management:Support monitoring oversight strategy to ensure quality and compliance across the organization with ... around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible...and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to… more
- Merck & Co. (Rahway, NJ)
- …and Support operations. -The teams operate within a framework of regulatory compliance and established high standards of Quality , Good Manufacturing Practices ... of state-of-the-art technologies for batch and continuous manufacturing -with a Quality First, Safety Aways Mindset. -The Director Manufacturing Operations (m/f/d)… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply (GCDS) Operations Team in Princeton ... to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical Drug Supply Project/Trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and clear communication with stakeholders and the project team. The Project Manager identifies and mitigates risks, maintains high- quality deliverables, and ... around rare diseases and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex filing activities, ensuring … more
- Merck & Co. (Rahway, NJ)
- …and material BOMs - . Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with network ... a strategy for product-specific adjustments and participating in associated platform Quality Risk Assessments (QRA). As applicable to Solution Supply and Weigh… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... SDTM and collaborating with CROs and other vendors to ensure high quality deliverables to support drug development processes and global submissions as required… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to maximize your potential with us? The Position The Associate Manager of Technical Production will be responsible for overseeing the technical aspects of ... to ensure that all video productions meet the highest standards of technical quality , efficiency, and reliability. Relationship This job reports to a Director in the… more
- Genmab (Plainsboro, NJ)
- …Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical ... Drug Supply Manager you will play a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage trials. In… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... the release of drug products for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for best practices as per Legend Biotech policies and GXP requirements.Ensure compliance of operational activities with GXP, quality , training, EHS, security ... in the treatment of multiple myeloma.Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role… 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 ... attainment of project milestones Develops solutions for process improvements; enhance quality and budget accuracy via financial modeling and automation Responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Strategic Sourcing activities. This position will ensure the acquisition of high- quality goods/services at the best possible prices by negotiating and monitoring ... ensure business objectives are met Manages and monitors organizational compliance with all established supplier agreements Provides strategic procurement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationship with key stakeholders and senior management within Finance, Legal, IT, Quality , Compliance and Product Safety. Leads an Operations team comprising ... based on KPIs, while delivering on the objectives of process agility, quality output, strong collaboration, and high productivity from team members. Ensures the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …on preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she ... failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing...of this analysis can be conveyed to the Maintenance Manager in a structured way so that he can… 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 ... Regulatory Affairs, CMR, Supply Chain, and HQ colleagues regarding labeling compliance to accomplish company goals. External relationships may include interaction… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responsibilities. Leads complex supplier negotiations and commercial contracts for quality and value creation. Enhances the procurement capability by helping ... and methodologies are understood and utilized. Serve as the lead "relationship manager " to proactively deliver strategic sourcing insights, optimal value and best… more
- Integra LifeSciences (Plainsboro, NJ)
- …pathways to advance patient outcomes and set new standards of care. This **Senior Manager , Quality Compliance ** will manage and provide oversight on ... Quality Compliance for change control projects and daily operations which...other applicable regulatory agencies. **SUPERVISION EXERCISED** Manages personnel supporting quality compliance areas including Change Control/Document Control,… more
