- Merck & Co. (Durham, NC)
- …the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System . Supporting areas such as Design, Commissioning, ... substance or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in a highly… more
- Tris Pharma (Monmouth Junction, NJ)
- …Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, Quality ... incumbent uses systems thinking and a holistic systems -based approach to drive compliance and assess... principles in the design (and resolution) of key quality management system elements to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including complete and accurate detail processed into the correct systems Quality monitoring activities to include CRM system case evaluation, Safety ... PSS Program Management team to ensure vendor compliance with all quality /safety requirements; educates on...requirements Understands PSP operations, including program business rules, SOPs, systems used (including CRM, Safety system and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices related to HRIS systems , incorporating relevant advancements to optimize system performance and functionality. - Data Quality , Testing and Release ... HR business processes, and business systems requirements. Accountable for global systems implementations inclusive of migrating from one system to another.… more
- Novo Nordisk Inc. (Durham, NC)
- …role will provide support & management of hardware & software on quality control laboratory computer systems . This includes improving reliability of the QC ... of Systematic Problem Solving, process improvement, & project management Operate within compliance with a Quality Mindset that focuses on risk management … more
- Merck & Co. (Durham, NC)
- …via in depth review of existing Deviation/ Corrective Action and Preventive Action Management and Complaint/Adverse Event Quality Systems , which will be ... Product Quality Complaint investigations, Adverse Event investigation, and Quality systems metric generation.-By providing administrative support, the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality . Leads strong and effective communication to global and ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....(SOWs). The AD will be responsible for providing supplier management support and oversight to the North America CMR… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality ... strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance ...and BPQLs, to internal and external stakeholders of R&D Quality .Support the oversight and management of CAPAs… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …is the senior leader and decision maker for the Quality Department and Quality Management System . This position is ultimately responsible for the product ... manufacturing and maintaining strong and efficient conformance to all quality expectations and compliance with all regulatory...standards. This position is the decision maker for the Quality Management System deployed throughout… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …helping to bridge the communication infrastructure between the various subunits of the Quality System and by ensuring accountability for the efficient execution ... of critical quality tasks. Fostering efficiency, maintaining compliance with...on an experienced paralegal or legal assistant's analytical, organizational, time- management , and investigative skills and offers an exceptional gateway… more
