- Repligen (Waltham, MA)
- …our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you will play a key role in aligning technology ... with GMP (Good Manufacturing Processes) and other regulatory requirements.Partner with process owners to optimize SAP and other enterprise applications for… more
- Insmed Incorporated (NJ)
- …with regulatory requirements while maintaining operational excellence. The Executive Director , Cybersecurity & Risk Management plays a critical leadership role ... Oversight: Oversee the CSV team, validation strategy and continuous process improvementEnsure compliance with GxP regulations and industry standardsFamiliarity with… more
- Merck & Co. (Rahway, NJ)
- …resources for technical support of capital projects in area of process , equipment, and/or automation responsibility, culminating in directing the coordination of ... financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory issues.- Provides technical, project management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …lessons learned from audits, assessments, inspections, metrics, deviations and or process improvements. Ensure adequate QA oversight of the GMP audit programs ... and retain all the records in order to ensure the traceability of audit process . Participate in the development of GMP audit certification program to ensure adequate… more
- Novo Nordisk Inc. (Boulder, CO)
- …managing employee relations, overseeing financial matters and driving continuous process improvement & projects Maintain effective communication, collaboration & ... and they understand their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning and aspiration plans… more
- Formation Bio (New York, NY)
- …will work closely with our business development, legal, clinical, CMC, and data/ engineering teams to on-board products with strong IP potential, and thereafter ... formulation findings, method of use patents, lifecycle management strategies, process -related discoveries and labeling-related IP issues Oversee trademark, trade… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality Leads, site Compliance Leads, Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain and PlanningRequirementsA minimum of ... flexible and responsive to frequently shifting priorities.Proficient in applying process excellence tools and methodologies.The candidate must be highly organized… more
- UTMB Health (Galveston, TX)
- …the Academic Enterprise and in alignment with the mission of UTMB. The Director will oversee the provision of Operations and Maintenance services, to include ... a measurable quality management program to include assurance, control and process improvement activities. Adheres to internal controls and reporting structure.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Finance, IT, and operational teams. Relationships This individual will report to a Director in Finance & Supply Chain. Daily, the individual in this position will ... Finance organization with frequent interaction at the manager, senior manager and director level. Moreover, the job regularly interacts with IT and data management… more
- Repligen (Rancho Dominguez, CA)
- …Rancho Dominguez, CA site and will report to the Sr. Director of Quality.ResponsibilitiesUse/application of investigative tools to perform investigations and root ... processes.Performing FMEA analysis, RCA, Gauge R&R studies, statistical evaluation, and process control activities to resolve and prevent quality and reliability… more
