- Novo Nordisk Inc. (Durham, NC)
- …functions in Department Quality Risk Management Make decisions on quality & compliance issues with little guidance Participate in process group ... preferably in the pharmaceutical industry Demonstrated expertise in Regulations & quality systems (eg, commercial product disposition, DV/CAPA, Change Control,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …supervision and conduct testing Core roles include communication, compliance , risk management , and use of current technology System Design and Specification ... position is responsible for maintaining and advising new projects on the Building Management System while collaborating with the Engineering team to provide… more
- Merck & Co. (Rahway, NJ)
- …the GCS Organization adheres to compliance standards set forth in the overarching Quality Management System (QMS). This role is critical in supporting a ... Job DescriptionAre you passionate about serving patients with quality products? Within our Research and Development Division, the Global Clinical Supply (GCS)… more
- Novo Nordisk Inc. (Boulder, CO)
- …and updating Customs Standard Operating Procedures (SOP's) as needed Authoring and implementing quality management system policies and SOPs for process ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- BioAgilytix (Durham, NC)
- …and compliance .Develop a roadmap for building a high-performing data management team, identifying roles in data engineering, quality , and automation ... a foundational data governance framework, with hands-on responsibility for data quality , access control, and compliance protocols.Define standards, build … more
- Eisai, Inc (Nutley, NJ)
- …for the conduct of clinical trials Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... protocol, amendments and/or biological licensing agreements. May also audit operating systems , processes and procedures. May support risk management operations,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …remediation and risk management in close collaboration with the organization's quality management system , to assure robust knowledge transfer and ... product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... realize your potential? The Position The Solution Architect on ICS (Industrial Control Systems ) is responsible for acting as a technical lead and trusted advisor,… more
- Eisai, Inc (Raleigh, NC)
- …along with Eisai Canada, Mexico, and Europe for import and compliance management .Effective communication, relationship building, and strong partnerships are ... along with Eisai Canada, Mexico, and Europe for import and compliance management .Effective communication, relationship building, and strong partnerships are… more
- Aequor (Thousand Oaks, CA)
- …MS Teams, SmartSheet, Miro Multilingual preferred, Spanish and Portuguese is a plus System knowledge; Tableau, Document Management Systems , SAP, Rapid ... as the primary liaison representing the country and region with Manufacturing, Quality , Regulatory Affairs, Corporate & Local Planning, and Product Delivery Teams… more
- Eisai, Inc (Exton, PA)
- …accordance with Eisai standards and senior management intentions. Through a GxP Systems Quality Assurance framework, the role is to provide assurance to ... control management processes and procedures for GxP systems as assigned.IT System Implementation and Maintenance:...SOPS, SDLC tasks, and other GxP Systems Quality Assurance processes for use in supporting compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to ... reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes in support of clinical development objectives.- Accountable for lab data management deliverables for all programs meeting quality and time expectations ... for the oversight of CROs pertaining to laboratory data management , LNR collection standards, and quality issue...and Lab Load Templates.- Accountable for oversight for Data Management resources, CROs, and vendors to ensure compliance… more
- Merck & Co. (Rahway, NJ)
- …drive their team's strategy.- The staff manager will be expected to monitor quality of project management deliverables and assign accountability for the ... Job DescriptionGlobal Project and Alliance Management (GPAM) sits in the R&D organization at our Company (known as our Company's Research Laboratories). GPAM… more
- Merck & Co. (Lower Gwynedd, PA)
- …direct support to automation asset maintenance, system security, data management , obsolescence initiatives and all SDLC and Compliance needs.Job duties ... as system administrator for equipment applications, including temperature monitoring systems , assisting in the management of controlled temperature units and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role ... of IT system architecture and cloud-based environments.Manage third-party vendors, system providers, and validation partners to ensure compliance , contract… more
- Merck & Co. (Rahway, NJ)
- …desirable. - Preferred Experience and Skills: - - Proficiency in using supply chain management systems and software, including experience with ERP systems ... (eg, SAP), demand planning tools, and inventory management systems . - Familiarity with data analytics/visualization software . - Familiarity with Good… more
- Merck & Co. (Rahway, NJ)
- …within the clinical supply planning function. - Proficiency in using supply chain management systems and software, including experience with ERP systems ... (eg, SAP), demand planning tools, and inventory management systems . - Proven record in project / portfolio management . - Knowledge of Good Manufacturing… more
- Merck & Co. (Durham, NC)
- …, Microsoft Word, Pharmaceutical Processing, Regulatory Compliance , Reliability Management , Root Cause Analysis (RCA), Strategic Thinking, System ... an understanding of maintenance processes, common equipment, and Computerized Maintenance Management Systems .Demonstrated ability to work independently as a team… more
- Merck & Co. (Rahway, NJ)
- …within the clinical supply planning function.- Proficiency in using supply chain management systems and software, including experience with ERP systems ... (eg, SAP), demand planning tools, and inventory management systems . - Proven record in project / portfolio management . - Knowledge of Good Manufacturing… more
