- Merck & Co. (Rahway, NJ)
- …and lifecycle management . This individual will oversee device risk management activities to ensure the delivery of high- quality products and efficient ... Job DescriptionThe Associate Principal Scientist, Device Risk Management Lead, is a crucial...experience in pharmaceutical development, device development, device systems operations, quality management , or a related area. Strong… more
- Insmed Incorporated (NJ)
- …ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a ... We are seeking an experienced leader to oversee cybersecurity operations, enterprise risk management , and Computer Systems Validation (CSV) program. This role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certification program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the ... risk management activities completion for vendors and to periodically review...strategy in QA GMP Audit processes for contribution of Quality Management System (QMS) establishment processes in… more
- Merck & Co. (Rahway, NJ)
- …formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality , Pharmaceutical Operations, ... Management , Process Analytical Technology (PAT), Professional Networking, Project Management , Quality Control Management , Regulatory Compliance,… more
- Bayer (Whippany, NJ)
- …and diverse minds to make a real difference, there’s only one choice. Senior Director , Digital Governance & LMR Lead The Senior Director , Digital Governance & ... teams to be accountable for the delivery of high quality , ethical standards of service. The role combines digital...AND RESPONSIBILITIES The primary responsibilities of this role, Senior Director , Digital Governance & LMR Lead, are to: Oversight… more
- Merck & Co. (North Wales, PA)
- …and Change Management - The complexity of categories and projects require high quality project and program management skills and a proven ability to manage ... Job DescriptionThe Global Packaging Procurement Director is responsible to lead the Packaging Center...of direct and indirect materials, performing the supplier relationship management , supply risk assessment with actions in… more
- Insmed Incorporated (NJ)
- … Director will be responsible, globally, for implementing the safety and risk management activities for clinical development; be responsible for safety ... you?About the Role:We are seeking a highly experienced Senior Director , DSPV Medical Safety to help us expand what's...surveillance, risk management , and risk communication… more
- Formation Bio (New York, NY)
- …tools to streamline workflows and accelerate decision-making. Drive cross-functional planning, risk management , and clear action tracking. Flex Capacity ... faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner… more
- Formation Bio (New York, NY)
- …with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk management by identifying and mitigating risks before they ... to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement strategies ... Clinical Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit-… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk and establish vendor quality scorecard.Support development and gathering of quality metrics for Legend's Quality Management Review (QMR).Support ... management of the Quality Management Review (QMR) program.Support continuous improvement efforts through the monitoring of audit metrics.Assist with the… more
- Insmed Incorporated (NJ)
- …to improve processes and set direction in related areas such as compliance, CRO management , risk management , etc.Ability to prioritize and manage multiple ... and procedures. Ensure compliance with all Company/Regulatory requirements & TMF quality standards.Work with outsourcing/procurement management to optimize the… more
- Merck & Co. (Rahway, NJ)
- …to go live with new equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level ... Job DescriptionThe Director , Technical Operations within Global Clinical Supply (GCS)...with upstream operations (eg manufacturing, devices) as well as Quality and Safety in ensuring GCS readiness to support… 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
- Merck & Co. (Rahway, NJ)
- …drug product, finished goods including combination products, and samples. Drive proactive risk management activities, including risk assessment, risk ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical ... engineering design, engineering analysis and testing, medical device design controls, risk management , test method/fixture development, design verification and… more
- Merck & Co. (Rahway, NJ)
- …for new product introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ... Process, Manufacturing Scale-Up, Mentorship, Packaging Engineering, Process Optimization, Risk Management , Root Cause Analysis (RCA), Social… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …presentation skills, power point, Visio, budget, resources, algorithms, projections, risk management and mitigation.Operational Oversight and Reporting: Oversee ... team, developing standard approaches that foster a reputation for outstanding quality , collaboration, rigor, and follow-through. Collaborate with the Head Global RD… more
- Cipla (Central Islip, NY)
- …manner to ensure avoidance of all actual and potential conflicts of interest Risk management Minimize impact of supplier shortages by proactively identifying and ... Job Title: Director - Procurement, Cipla North America Reports to:...to identify opportunities for cost savings, process improvements, and risk mitigation. Develop, manage and monitor RFQ (Request for… more
- Merck & Co. (Boston, MA)
- …strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare ... Consulting, Collaborating, Communication, Data-Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management… more