- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team, responsible for spearheading risk management ... device risk management activities, ensuring adherence to industry standards. Lead risk management workshops and training programs, facilitating… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... Are you ready to experiment with us? The Position Lead and own the strategic vision for commercial innovation...viability, and impact assessments to inform leadership decisions and de- risk scale-up. Novo Nordisk is currently in the process… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... in-scope service contracts with third-party vendors, across low, medium, high business risk and complexity, from intake to execution, in collaboration with SME… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness ... Kaiser, institutions, GPOs) and other area/regional accounts. Acts as PCOR Account Lead responsible for leading company response from Deal to Contract (includes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities in collaboration with the CRO, feasibility team and the study team.-Assist Data Management with development of the clinical database (edit checks, CCG ... file is complete and accurate for assigned stud(ies).-Ensure that a study level operational risk management plan is in-place and applies a smart- risk taking… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigation Lead is an exempt level position reporting to the...Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking Validation Lifecycle & Technical Lead as part of the Global MSAT team based in Remotely. Role ... cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. Role ... OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and… more
- Merck & Co. (Rahway, NJ)
- … Lead /Support continuous improvement initiatives for design control and risk management processes Identify and eliminate process inefficiencies using ... and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying… 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
- Formation Bio (New York, NY)
- …regulatory requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of quality risk assessment ... will have the opportunity to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug… more
- Merck & Co. (Rahway, NJ)
- …, Packaging Procurement, Production Planning, Raw Material Sourcing, Results-Oriented, Risk Management , Strategic Sourcing, Strategic Thinking, Supply Chain ... in the US and Ireland where our company has its largest manufacturing footprint. Lead cross functional teams through the Sourcing Management Process at global… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... with a strong background in the biotech industry to lead digital transformation initiatives. This role will focus on...data , Spotfire, Thoughtspot, data lakes, dashboards, data models, etc.).Proficiency in portfolio management software… more
- Merck & Co. (Rahway, NJ)
- …in pharmaceutical, biotechnology, or medical devices with proven success in Project management and team leadershipDemonstrated ability to lead and develop teams, ... Process Improvements, Clinical Supply Chain Management , Contract Management , Customer Alignment, Customer-Focused, Data Compilation, Detail-Oriented,… 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)
- …Communication, Data -Driven Decision Making, Influencing Skills, Leadership, Management Consulting, Oncology, Prioritization, Risk Management , ... strategy development, strategy execution and value realization, enterprise strategic planning, risk management , and strategic venture investments in healthcare… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Safety, will lead the development and implementation of integrated project/product risk management strategies aimed at achieving the optimum benefit- risk ... but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned projects/products.Define and implement… more
- Merck & Co. (Rahway, NJ)
- …equipment and infrastructure (eg Quality risk assessment, safety assessment, data integrity, change management , etc.)Provide next-level support to CSO when ... (CSO), Logistics and Regions, and External Partnerships & Supply (EPS).- The technical lead owns business continuity of GCS facilities and equipment as well as… more
