- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Finally, this position has advanced skills in continuous improvement, project management , change management , and risk managementResponsibilities: Leadership, ... trials and submissions work.Proactively identifies and manages risks for the data management function and supports functional risk identification/ management … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM ... in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience...Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … is consistently and proactively represented at program level and support proactive quality risk management process.Interact with the audit and compliance ... identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Merck & Co. (Rahway, NJ)
- … Assurance Systems, Quality Management , Quality Oversight, Quality Risk Management , Quality Systems Compliance, Regulatory Compliance ... Research, Policy Development, Product Commercialization, Project Leadership, Project Procurement Management , Project Risk Assessments, Quality Assurance… 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 ... proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering, Biomedical… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS)… more
- Merck & Co. (Rahway, NJ)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... including assessment of the probability of regulatory success together with risk mitigation measures.-Lead development and execution of global product and project… more
- Merck & Co. (Rahway, NJ)
- …talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including ... accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for… more
- Merck & Co. (Rahway, NJ)
- …Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , ... and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also… 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 ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies ... a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and strategic alignment through actionable… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams ... and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has advanced skills in continuous improvement, project management , change management , and risk management Responsibilities: Leadership, Direction, and ... and submissions work. Proactively identifies and manages risks for the data management function and supports functional risk identification/ management … more
- Merck & Co. (Rahway, NJ)
- …Making, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, People Management , ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and support proactive quality risk management process. Interact with the audit and ... identified through audits, inspections, internal meetings, remediation and risk management in close collaboration with the organization's quality … more
- Otsuka Pharmaceutical Co., Ltd. (Princeton, NJ)
- …technology landscape (network, application, data and endpoint). Expert understanding of risk management , compliance, and governance frameworks related to ... Job Summary The Director , Information Security Architect is responsible for providing...services in line with industry frameworks and the company's risk appetite. This role exhibits and continually develops expertise… more
- Everest Insurance (Warren, NJ)
- …discipline and focus on creating long term value through underwriting excellence and strong risk and capital management . At Everest, we believe that our future ... Claims organization. The Claims Operations Associate I reports to the Director , Claims Operations. Position Description Support the Claims organization with initial… more
- Hackensack Meridian Health (Edison, NJ)
- …processing of invoices. Provides administrative support for the VPs within WHS., Enterprise Risk Management . Assigned to special projects and tasks on request. ... reviews data and identifies opportunities to improve. Responsible for preparing the director reports related to department financial statistics, quality reports… more
