- Legend Biotech USA, Inc. (Raritan, NJ)
- …leadership and build an exceptional team to manage the Quality functions ( Quality Assurance, Quality Systems , Quality Control), including hiring, ... are effectively linked.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will be assigned, as… more
- Insmed Incorporated (NJ)
- …one compound to ensure all are delivered on time, within budget and with high quality . This role may manage clinical operations team members, as delegated by ... an 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of… more
- Insmed Incorporated (San Diego, CA)
- …for the future of science, we're in. Are you?About the Role:We're looking for a Director , Clinical Scientist for the Gene Therapy Clinical Development team ... what's possible for patients with serious diseases. Reporting to the Executive Director , Clinical Development, you will support and work predominately with… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand ... developing and executing strategic plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …strong knowledge of regulatory frameworks (eg, FDA), GCP guidelines, and quality management systems .Preferred but Not Mandatory: Medical practice experience ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management System (QMS) establishment processes in collaboration with GMP Quality System function. Supports the development and implementation of key ... activities involving but not limited to supplier qualification program, CMC audit, clinical /IMP vendor audits and overall GMP vendor audit program. Establish lessons… more
- Novo Nordisk Inc. (Boulder, CO)
- …the Quality Assurance (QA) function and serves as the leading expert in quality , compliance, and quality management systems (QMS). Provide direction & ... leadership, managing business integration & site strategy to support manufacturing of clinical product through testing and quality programs to ensure product… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality , or cell ... people management and leadership experience is required.Experience working with quality systems is required.Extensive knowledge of chemical, biochemical… more
- Merck & Co. (Rahway, NJ)
- …global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ... Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems , Medical Device Regulations, Medical Devices, Medical… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... execution and management of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development,… more
