- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management , human factors, technical integration, assembly automation, etc.), ... development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Aequor (Thousand Oaks, CA)
- …Deep understanding of Risk Based approaches and its impact with Data Management /Site monitoring operationally - consider the role of both Data Management and ... knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, Risk -based Quality Management etc. Determine key performance indicators (KPIs)… more
- Merck & Co. (Rahway, NJ)
- … Management , Portfolio Management , Project Management , Project Portfolio Management (PPM), Project Risks, Risk Management {+ 5 more}-Preferred ... company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain...At least 5 year s of experience in project management - - At least 5 years of experience in… more
- Merck & Co. (Rahway, NJ)
- …Management , Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Financial Risk Management (FRM), Good Manufacturing Practices (GMP), ... Management , Project Management , Project Portfolio Management (PPM), Project Risks, Risk Management {+ 5 more}-Preferred Skills:Job Posting End… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... responsible for providing strategic leadership, technical expertise, and project management in the scale-up, development, commercialization, and transfer of medical… more
- Merck & Co. (Durham, NC)
- …goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).- ... ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director, External Manufacturing Operations will also assist… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function… more
- Merck & Co. (Rahway, NJ)
- …and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program ... and design controls for the assigned projects while adhering to management -approved strategic plans, corporate policies, and providing clear communication to… more
- Merck & Co. (Rahway, NJ)
- …E, Reg Z, PCI DSS, and FFIEC guidelines.Champion the credit union's enterprise risk management strategy of "Slow Down, Stop, Escalate"Team LeadershipLead and ... and track KPIs for performance, member experience, and operational efficiency. Risk & ComplianceMaintain strong controls and procedures to comply with… more
- Merck & Co. (Rahway, NJ)
- …Project Management , Project Portfolio Management (PPM), Publications Management , Regulatory Compliance, Risk Management , Sourcing and Procurement, ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (San Francisco, CA)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with the DSCS Digital Leadership Team to drive the execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug… more
- Novo Nordisk Inc. (Durham, NC)
- …and SME to operate within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation of effective change ... assignments within compliance with a Quality Mindset that focuses on risk management and mitigation. Utilize the appropriate cLEAN® tools when relevant Lead… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to work ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Merck & Co. (Rahway, NJ)
- …-The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. ... following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Merck & Co. (Rahway, NJ)
- …launch planning tool, ensuring adherence to timelines, budgets, and resource allocation. Risk Management : Identify potential risks and interdependencies across ... to ensure accountability and ownership of launch performance.Operational ExcellenceProgram Management : Oversee the execution of launch readiness activities within… more
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management , and leading matrixed teams through influence to meet NPI ... cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... program progress, issues, and mitigation plans to the senior management .Innovative mind-set demonstrated by technical accomplishments, external presentations, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… more
- Merck & Co. (North Wales, PA)
- …of status update reports, study close out activities).Leads team for timeline management , risk identification and mitigation, issue resolution.May facilitate and ... as part of a global, cross-functional team. You will apply project management , communication, and collaboration skills in support of our clinical trials.Job… more
