- 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
- United Nations Federal Credit Union (New York, NY)
- …and department protection related vendor information in Vendor Point; assist the Third-Party Risk Management department in assessing the risk profile of ... and statistical data . Utilize tools to analyze and collaborate with management to decipher trends leading to executive management recommendations. Prepare… more
- RMS Computer Corporation (New York, NY)
- … * Resource management * Project communications * Risk & issue management * Procurement management * Data centre design * Vendor management ... infrastructure design and implementation * Data circuit management * Network design and topology * Telephony and...budget, procurement and communication * Developing and maintaining a risk management plan throughout the project lifecycle… more
- 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
- 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
- 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
- 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
- ValSource, Inc. (Rahway, NJ)
- …is currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting ... compliance with FDA, GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management : Interface with clients, lead teams of validation… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... Position Description: The Director of Commercial Strategy Development will lead and support strategy development for enterprise-critical commercial initiatives,… more
- Merck & Co. (Rahway, NJ)
- …and consensus facilitation and awareness of when to apply each.- Leverages scientific data to make disciplined risk -based decisions and shown to be capable ... patients we serve. Problem Solving and Innovative Thinking:-- Gathers and analyzes data and effectively responds to new or complex situations, developing creative… more
- Eisai, Inc (Nutley, NJ)
- …Drafting and Negotiation, Industry/ Regulatory Knowledge, Legal & Reputational Risk Management , Legal Knowledge, Mentoring/ People Development, Stakeholder ... and hands-on attorney role whose job will be to lead Eisai's privacy initiatives across the US and Canada...privacy solutions that enable the Company's innovation while protecting data and mitigating risk . The role requires… 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
