- Legend Biotech USA, Inc. (Raritan, NJ)
- … team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of autologous ... to advance the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality… more
- Merck & Co. (Durham, NC)
- …required to successfully support the QC laboratory Team to include the following: Quality Manager overseeing analytical testing and personnelLead the team and ... packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …shape the quality landscape across regions. This may include assessing regulatory intelligence and industry best practices and sharing with the BPQLs and ... Quality ).Participate and support lessons learned activities from audits, regulatory authority inspections, and internal process deviations delivered to program… more
- Merck & Co. (Durham, NC)
- …bulk active ingredient, finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the ... to work cross-functionally with existing Laboratories and organizations. The Laboratory Manager will be responsible for start-up testing in new laboratories using… more
- Merck & Co. (North Wales, PA)
- …processes, and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high- quality standards.- Product managers ... Research & Development Division ) is looking for Product Manager - PV Case Intake and Processing. Reporting into...teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality … more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... supply of API, during the execution of the job duties, the senior manager should seek to actively support continuous improvement initiatives and identify wherever… more
- Merck & Co. (Millsboro, DE)
- …overseeing the preparation, usage and storage of sterile tanks. The area manager ensures all schedules are met while following all safety and standard ... operating procedures to meet company product quality standards. Primary Responsibilities Supervision of facilities, equipment and personnel in Central Services Area,… 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 ... and immune disorders. Summary The purpose of the Project Manager (RACMC) function is to lead and/or support complex...submitted and approved on time, and to the required regulatory standards, contributing to the organization's success and … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... teams, clinical safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug development processes and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager of CRA Monitoring Oversight and Excellence is responsible for the support ... a fast paced and results-oriented environment. This role will embody principles of Quality by Design (QbD) as it directly relates to risk-based monitoring (RBM) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… 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 ... quality practices in accordance with state and federal regulatory requirements.Strive to reduce non-conformances in supported areas by dedicatedly driving… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team based in Raritan, ... individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Global Service Manager (GSM) focusing on Incident, Problem, and Change is responsible for the ... workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and Inspections, and...on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
