- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with business functions. Provide expert guidance to enable successful inspections .Lead/Support local inspections by providing adequate systems ... issues in a timely manner for earliest resolution, Regulatory Inspections :Facilitates regulatory inspection preparation, management, and follow-up, ensuring… more
- Core48 Transport (Mercersburg, PA)
- …CORE48 Transport, LLC is a bold, new name in trucking -- backed by nearly 60 years of transportation expertise. We're looking for dependable, safety-driven OTR ... Stay compliant with DOT regulations and CORE48 procedures Perform pre-trip inspections , plan fuel-efficient routes, and manage your time effectively Deliver with… more
- Eisai, Inc (Nutley, NJ)
- …Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. #LI-CCEisai Salary Transparency Language:The ... of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system.… more
- Eisai, Inc (Tampa, FL)
- …in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language:The base ... North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …the production as well as supporting trend reports and complex cases owned by the area. Presents this during audits/ inspections Maintain effective communication ... in production-driven improvements to the process and equipment on shopfloor. Drive an own minor improvement initiatives and support colleagues Develop, write… more
- Insmed Incorporated (NJ)
- … inspection readiness activities and provide support during regulatory inspections .Monitor industry trends, regulatory updates, and guidance documents to ensure ... and other GxP areas, with a focus on data integrity, validation, and inspection readiness. The Sr. Quality Engineer will partner with IT, business, and vendor… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of ... to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and continuous improvement. Manage DSI's Strategic PV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of ... in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review Prospective & Retrospective Quality Review of cases Regulatory Intel & Inspection Readiness Maintains up to date knowledge of the regulations and guidelines ... issued by FDA and ICH as well as other industry...and execution of internal and external audits and regulatory inspections Ensure documentation and processes are audit-ready and aligned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionLocation: US - Remote/Hybrid/On-site as required by manufacturing engagement Reports to: Head of Manufacturing Systems Grade: Senior / R5-equivalent - ... translate shopfloor realities into robust digital and control solutions. Drive architecture-level decisions and integration approaches across MES/MOM, ERP, PLM,… more
