- Merck & Co. (Rahway, NJ)
- …approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with ... of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high- quality...Director , as a senior member of the Global Regulatory Affairs and Clinical Safety: Chemistry, Manufacturing and Controls… more
- Merck & Co. (North Wales, PA)
- …for higher complexity products including assessment of the probability of regulatory success together with risk mitigation measures.Lead the development, ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… more
- Tris Pharma (Monmouth Junction, NJ)
- …meet clinical trial planning and execution obligations Fosters a culture of quality -by-design in trial oversight and risk management across outsourced clinical ... immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations provides expert… more
- Merck & Co. (North Wales, PA)
- …Quality Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices ... QMS team for QMS updates as needed.Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …work model (combination of in-office and work from home abilities).The-Associate Director , Digital & Omnichannel Innovation for US Oncology-focuses on digital health ... and may not be limited to: Strategically develop and deliver high quality digital health strategies and emerging customer experience and/or Omnichannel pilot… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections, raw materials release, and compiling, trending and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external (especially regulatory , but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and management of assigned ... well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety, will be a product safety lead or part of a… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Merck & Co. (Rahway, NJ)
- …clinical siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program ... with a matrixed reporting relationship to functional groups in development, quality , safety, facilities management, analytical, finance and regulatory .-FLEx was… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good...necessarily be limited to, the following:Facilitate and maintain a risk -based and scientific-based quality system to support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation ... assessments to prioritize investigations based on potential impact on product quality , patient safety, and regulatory compliance. Address recurring deviations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... data collection services on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse external providers for clinical… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance, the Director , Quality ... related to QC Lab and operationsPartners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may… more
- Tris Pharma (Monmouth Junction, NJ)
- …The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality , etc. to identify, evaluate ... opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety...potential risks mitigation, etc. Collaborates with appropriate clinical, medical, quality and regulatory counterparts and others across… more
- Merck & Co. (Rahway, NJ)
- …to relevant information across multiple systems and platforms.Establish data quality control processes to ensure data accuracy, completeness, and ... disease-specific databases (eg, Cancer Genome Atlas).Stay informed about the availability, quality , and limitations of various data sources and their relevance to… more
- Insmed Incorporated (Bridgewater, NJ)
- … risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit- Risk Assessments and ... Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team.… more
- Merck & Co. (Rahway, NJ)
- …site, region and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance ... are completed in accordance with identified target dates.Review and/or approve regulatory permits, inspection outcomes and audit report findings to assure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs. ... program level and along the clinical trial process in support of a proactive quality risk management process. Interact with the audit function. The respective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management. He/she will assess project issues and develop resolutions to meet ... smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to Senior… more
