- Tris Pharma (Monmouth Junction, NJ)
- …skills needed and/or licenses or certificates preferredCertified Quality Manager , Engineer or AuditorExperience with drug -device combination products (highly ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The 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...a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early and late-stage… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.Genmab is seeking a Clinical Drug Supply Manager to join our Global Clinical Drug Supply ... locations to work according to our hybrid work arrangement.Responsibilities/tasks:Act as Clinical Drug Supply Manager , of the following tasks:Global Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a project manager /leader in planning and executing strategies for global drug development: early stage, late stage and life cycle management preferred10 or More ... Sr Director GPM&L is accountable for delivering an integrated drug development strategy and tactical plan including options analysis...to ensure delivery of projects within cost, time and quality requirements. As a leader in GPM&L this position… more
- Formation Bio (New York, NY)
- …is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more ... technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …release documentation. Participates as a cross-functional team member to provide product quality /GMP support and assures proper documentation of drug product ... expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality… more
- Merck & Co. (Rahway, NJ)
- …arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Laboratory Compliance ... Manager role is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external stakeholders communicating project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …industry.Excellent knowledge of project management discipline and its application to drug development required to deliver time, cost, quality , and ... Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations...partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo that provide services through the supply of commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, ... will withstand regulatory inspections by regulatory authorities and regular audits. Drug Product Management: Supports technically the operational activities which… 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 ... We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical tasks related to final printed pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic and operational plans for all activities ... with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical..., visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance ... investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...years of direct QA experience Experience in a licensed drug or biologic facility regulated by the FDA, EMEA… more
- Uline, Inc. (Wichita, KS)
- …across North America know and trust, is looking for an experienced Sales Account Manager to build our growing Wichita, Kansas market.Your role in our Sales team is ... to help businesses from every industry discover quality products with speed and service you'll be proud...and packaging materials with over 9,000 employees across 13 locations and 15 sales offices.Uline is a drug -free workplace.EEO/AA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Lab Oversight Specialist role is ... an exempt level position with responsibilities for providing quality oversight over the site Quality Control laboratories responsible for testing of… more
- Merck & Co. (Durham, NC)
- …a reliable global manufacturing network that's devoted to delivering a high quality , reliable supply to customers and patients on time, every time.-Our Manufacturing ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… more
