- Eisai, Inc (Nutley, NJ)
- …mgmt. activities. #LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance - Remote-Based is from ... management and oversight of the Quality management system . This role is responsible for Good Clinical.../CQA conducting a broad range of audits.Experience with GxP systems including general knowledge of CSV and associated regulations.Proven… more
- Eisai, Inc (Baltimore, MD)
- …environment and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical ... and for-cause audits Knowledge of data integrity controls and systems quality for clinical area...Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is… 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
- 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
- Merck & Co. (Rahway, NJ)
- …key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to ... continuous improvement initiatives to enhance the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . Stay updated on… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....The Position The position serves as the lead of Clinical Data Science & Evidence (CDSE) operations. In their… 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
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:The Associate Director , Programming provides technical leadership and ensures adequate programming support for ... of Programming strategies and efficient execution of analyses for assigned clinical projects. Collaborates with cross-functional team members within Biometrics, … more
- Insmed Incorporated (NJ)
- … Clinical Development, and Commercial Effectiveness to deliver high quality , strategic training plans. Partner with legal/compliance to ensure appropriateness of ... and for the future of science, we're in. Are you?About the Role:The Director , Global Medical Training Strategy will be responsible for developing the strategic… more
- Insmed Incorporated (NJ)
- …consistent with NIST and FDA data protection standards.Partner with Legal, Compliance, Clinical Operations, Quality and R&D to proactively manage risk across ... EU GMP Annex 11, and GAMP 5 guidelines a plus .Experience collaborating with Quality , IT, and business stakeholders to ensure systems are validated and remain… 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
- Merck & Co. (Rahway, NJ)
- …microbiological investigations Review and approval of data and reports. SOP development. Quality System experience. Thorough working knowledge of GMPs, ICH, ... formulations, and their processes for non-sterile and sterile products. The Director will also collaborate with Development Quality , Pharmaceutical Operations,… more
- Merck & Co. (Rahway, NJ)
- …Experience supporting compliance investigations and change management. Experience working with Quality systems . Experience working in an environment with an ... pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the...compliance representatives, and other team members to ensure the quality and safe delivery of clinical supplies,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …GxP Compliance Training and Patient Safety Operations. This role ensures that Safety/ Quality /Training processes, systems , and resources are optimized to support ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...departments to assist with the implementation and optimization of safety/ quality /training systems Drive adoption of digital tools… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including FDA and ICH regulations and guideline Expertise in safety databases and quality systems Knowledge of NNI supported disease states preferred (eg, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …understanding of GxP training compliance, FDA regulations, ICH Guidelines, and quality management systems Exceptional project management and communication skills ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems , Microscopies, Negotiation, Optical Microscopy, Product ... Commercialization, Production Process Development, Project Management, Prototyping, Quality Management Systems (QMS), Self Motivation {+ 3 more}Preferred Skills:… more
- Insmed Incorporated (NJ)
- …method validation/transfer, formulation work, and scale-up.Drive phase-appropriate quality system improvements for development-stage programs.Participate ... supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems , regulatory requirements (21 CFR Parts 210/211,… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... 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
