- Daiichi Sankyo, Inc. (Bernards, NJ)
- …epidemiological data , and regulatory requirement synthesize into a coherent risk management strategy.Represents the CSPV department as subject matter expert ... all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily...evaluation, and if applicable, proposed actions (eg, changes to product information and/or other risk minimization measures)… more
- Merck & Co. (Rahway, NJ)
- …Planning (MRP), Microsoft Power Apps, Portfolio Management , Procurement, Project Management , Risk Management , SAP Enterprise Resource Planning (ERP) ... Management , Clinical Supply Chain Management , Clinical Trial Management , Clinical Trials, Cross-Functional Team Leadership, Data Analysis, Demand… more
- Merck & Co. (Rahway, NJ)
- …exploring alternative ways to view and solve problems to achieve results Drive proactive risk management activities, including risk assessment, risk ... thermal and distribution qualification for pharmaceutical products.Strong understanding of risk management principles.Strong strategic and analytical thinking,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director, Clinical Safety MD, will lead the development and implementation of integrated project/ product risk management strategies aimed at achieving the ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA stakeholders and CROs to ensure high ... with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through...Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of… more
- Merck & Co. (Rahway, NJ)
- …drug product , finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... and external stakeholders. Required Skills: Biopharmaceutics, Biopharmaceutics, Business, Change Management , Combination Products, Compliance Packaging, Cross-Cultural Awareness, Data… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social Collaboration,… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods ... blisters) meet safety, efficacy, quality, and robust supply standards. Drive proactive risk management activities, including risk assessment, risk… more
- Merck & Co. (Rahway, NJ)
- …and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods ... exploring alternative ways to view and solve problems to achieve results. Drive proactive risk management activities, including risk assessment, risk … more
- Merck & Co. (Rahway, NJ)
- … Management , Clinical Supply Chain Management , Clinical Trial Management , Clinical Trials, Cross-Functional Team Leadership, Data Analysis, Demand ... at clinical development related meetings (ie, Clinical Trial Teams) and product -development related meetings. The incumbent must have demonstrated understanding of… more
- Merck & Co. (Rahway, NJ)
- …ingredients (API) process characterization work by learning and utilizing Quality Risk Management methodologies and tools for statistical design of ... Process Characterization, Process Design, Process Improvements, Process Scale Up, Product Formulation, Protein Purifications, Quality Risk Assessment, Reaction… more
- Merck & Co. (Rahway, NJ)
- …The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary.Primary Responsibilities: ... scientists supporting excipients, package component, medical device component, and combination product release testing across the entirety of our non-sterile and… more
- Merck & Co. (Rahway, NJ)
- …participants with hands-on exposure to finance, accounting, auditing, analytics, risk management , and special projects.Throughout the program, individuals ... Management , Business Processes, Business Studies, Capital Budgeting, Cash Management , Corporate Financial Planning and Analysis (FP&A), Data Analysis,… more
- Merck & Co. (Rahway, NJ)
- …and impact on biological activity. Strong expertise in interpretation of characterization data in context of broader process and product development, critical ... using quality by design principles and with focus on comprehensive life-cycle management . Mentor and supervise junior colleagues; coach, and develop talent within… more
- Formation Bio (New York, NY)
- …carried out efficiently and effectively. Ensure the appropriate identification, evaluation, and management of risks associated with product quality. Build strong ... regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation ... program to enable robust production, testing and release of product to patients.Key Responsibilities Executes the commissioning, qualification, requalification,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tracking of quality metrics while ensuring high quality and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations ... within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight for trending of quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates ... Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting… more
- SMBC (New York, NY)
- …risks are properly reflected in the models. Support long- and short-term planning, new product development, ALM and risk management meetings. Network within ... potential loss across different types of risks. Establish thresholds, at- risk levels and exposure limits by product ...risk . Have a solid understanding of information technology, data management and statistical analysis to create… more
- SMBC (New York, NY)
- …institutional clients and ongoing product support and updates. Partner with risk management to improve portfolio risk assessment. **Qualifications and ... ensure quality control, proof for errors and help identify data trends for next level review. **Role Objectives: Delivery**...support the overall desk. Work with compliance, legal and risk management to broaden working knowledge of… more
