- Novo Nordisk Inc. (WA)
- … risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a continued practice centered on Quality by Design, Clinical Trial Risk Management , efficient Issue Management , and Continuous Improvement.Supports SVO ... team who support GCO Quality by Design, risk and issue management . This team will...of activities within remit/scope. Ensure appropriate resources (employee and/or contractor- based ) are available to support current and future clinical… more
- Merck & Co. (Durham, NC)
- …drug substance or drug product.GMP experience with qualification of equipment.Experience with Quality Risk Management .Project Management experience in ... project proceed in compliance with cGMP, regulations, and our Company's Quality Management System.Supporting areas such as Design, Commissioning, Qualification… more
- Merck & Co. (Durham, NC)
- … system initiatives and continuous improvements.-Core responsibilities:Supports the deviation management program including the coordination of managing Quality ... application of cGLPs and cGMPs.Experience with batch release, and quality systems management ;-Preferred qualifications:Preferred Experience and Skills: Strong… more
- Merck & Co. (North Wales, PA)
- …Manufacturing Division organization, specifically in Digital Quality and Labs, Digital Quality Operations, Content Management Product Line Team. This team is ... experience preferred. Knowledge of Kneat or similar paperless validation management software. Quality /Regulatory and Digital Enablement experience. Demonstrated… more
- Merck & Co. (Rahway, NJ)
- …Portfolio, Programme, and Project Support, Program Management , Project Management , Risk Management , Stakeholder Relationship ManagementPreferred ... ensure that releases are delivered on time, within budget, and with minimal risk .The Release Management Senior Specialist is responsible for the following:Work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Director, Analytical Lifecycle Management as part of the Technical Development team based out of our Raritan, NJ. Role Overview The Director of Analytical Method ... Lifecycle Management will be responsible for working with a cross-functional...based on impact, time and improvement cost, and risk associated with changes Identify approaches to improve method… more
- Merck & Co. (North Wales, PA)
- …of the company Manuals Department and has responsibility for the following:Editorial quality for assigned sections of the company Manuals Professional and Consumer ... versionsDatabase management and maintenance to ensure content accuracy across digital...collaboration with external stakeholders, such as customer-facing commercial, or research- based roles, will be expected to comply not only… more
- Catalent (St. Petersburg, FL)
- …patient, consumer and Catalent employee. As an integral member of the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be ... in support of supplier integrity and oversight. The Supplier Quality Regional Lead will oversee management of...maximise audits conducted during one trip ie grouped audits based on location Development of metrics to provide visibility… more
- Catalent (St. Petersburg, FL)
- …Supplier Quality Director approval Act as a liaison between suppliers and the quality teams globally during the management of supplier quality issues ... Quality Auditor Position Summary: Catalent is a global,...be p erforming audits, generation of audit reports and management of supplier CAPA to ensure required actions are… more
- Merck & Co. (Rahway, NJ)
- …within pharmaceutical industry, including change management and deviation management .Experience supporting internal and external quality audits.Learn more ... available at the Rahway, New Jersey research facility.-The Sample Management Specialist will work as a part of the...the integrated Compliance CoE and drive a culture of quality and operational excellence across the global AR&D network.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed.Partner with CQM to develop a strategy to help address facilitation of risk - based periodic review/update cycles specifically for identified high- risk ... areas (eg clinical research & development, clinical science, clinical quality assurance, project management ) preferredStrong leadership, collaboration,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Assessment and Prioritization: Conduct risk assessments to prioritize investigations based on potential impact on product quality , patient safety, and ... Management will provide strategic direction and leadership for the investigations management system. Working closely with the Quality Senior Manager, this… more
- American Honda Motor Co Inc (Marysville, OH)
- …Operating Board (NAROB) and senior executives across North America to strengthen risk management , internal controls, and governance processes among Honda and ... around the world who are trying to do things based on their own initiative and that helps people...of their operations from a compliance, controls, efficiency and risk management viewpoint.The role of the Senior… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …through meeting management , development plan/timeline management , scope management , stakeholder management , risk /issue management , finance ... diseases and immune disorders. SummaryThis position is responsible for supporting project management and operational activities as part of the Project Management … more
- Novo Nordisk Inc. (Tacoma, WA)
- …the diabetes educator will interact with key health system departments including: quality , care management , population health, diabetes treatment centres, and ... relationships with key decision makers responsible for the direct management and care for the "at risk "...Deeper understanding of Advanced Alternative Payment Models and other quality incentives that are focused on value- based … 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
- Eisai, Inc (Nutley, NJ)
- …stakeholders from EIT and leaders across regions in Compliance, Ethics, Risk Management , Legal, Data Privacy, and Information Protection.Security ... recovery testing.Regularly review adherence to standards.Oversee regional security vendors.Prioritize risk - based reduction efforts.Manager investigations.General Compliance Activities:Maintain an… more
- Merck & Co. (Durham, NC)
- …RBAM assessments and owns area specific reliability actionsResponsible for spare parts risk - based assessments and identification of new parts to replace obsolete ... and provide the best-in-class services with the final goal of delivering our high- quality vaccines to the patients around the world with our core principle of… more
- Aequor (Thousand Oaks, CA)
- …and safety. Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate ... equipment design while minimizing project cost and schedule impact ( risk - based approach). Oversee development of validation protocols in line with CQP,… more
