- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... within the Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …initiatives and assesses their impact.Understand data/metrics/key performance and quality indicators to support vendor/CRO oversight of clinical ... for risk and issue management with strategic development partners.Close partnership with clinical quality management and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of excellence to identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of ... with clinical development.Review, approve and/or drive related process related improvement to the diversity and patient voice space. This includes gathering… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tracking systems are updated (eg Global Project Management System, GPMS). CRO and Quality Oversight: Responsible for management of CRO(s) performance to ensure ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions in...functional integration and delivery of items (eCRF, EDC, IXRS, Quality Oversight Plan etc) per the study plan. Oversee… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical ... as required. May serve on or lead global initiatives (eg, process improvement , Protocol review, training, SOP development, other Clinical (oncology) Development… more
- Novo Nordisk Inc. (Irvine, CA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; ... external partners relevant to the planning and implementation of clinical trials and improvement /innovation projects for NACD...services/tasks in support of the planning and implementation of quality driven clinical trials, in line with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with ... and LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan… more
- Merck & Co. (Philadelphia, PA)
- …is responsible and accountable for the organization, strategic direction, and overall performance of the eSSC. Ensures sound clinical development principles are ... incorporated into the services provided by the eSSC. Ensures consistent, high quality and standard processes are complied with, and meet worldwide regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with ... & Leadership Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as external investigators is expectedThe CS Group Lead will also ensure the writing of high- quality clinical trial protocols, review of clinical data and ... but not limited to SCORE, DRF - Create a performance -based team culture with clear accountability and a sense...requiredMay serve on or lead global initiatives (eg, process improvement , Protocol review, training, SOP development, other Clinical… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Senior Specialist provides expertise in the coordination of resources and equipment pertaining to qualification/validation activities ... supporting the vaccine expansion facility. Primary Responsibilities: The Quality Senior Specialist will be responsible for comprehensive management of all activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements ... risk areas/process improvement to stakeholders via the QMS scheme (ie, Quality Management Review, Quality Review Board) across the global CSPV organization… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Compliance Lead as part of the Quality team based in Raritan, ... NJ. Role Overview The Quality Compliance- Lead Auditor CAR-T is responsible for regulatory...compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships with external partners relevant to the design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg ... with multiple internal stakeholders relevant to the design & implementation of clinical trials improvement /innovation projects for NACD & Novo Nordisk (eg,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and any specialty vendors.Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure ... needs this position may take leadership and/or will participate in process improvement initiatives that are at the intersection of technology, process and analytics… more
- Aequor (Thousand Oaks, CA)
- …and timing are understood. ? Serve as the primary interface with Clinical Development, Quality , Biostatistics, Regulatory Affairs, Corporate Planning, and ... organizational or program management (leading teams, cross-functional problem solving, performance management, budget oversight, process development and improvement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …working, leveraging both quantitative and qualitative means. Candidate will define Key Performance Indicators, Key Quality Indicators, Key Risk Indicators, and ... key milestones at Study, Country, and Site Level to gauge clinical trial performance . Build and Maintain Metrics Catalog, Dashboards Catalog along with strategy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for maintenance and metrology support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing. This individual will partner with ... requirements. This individual will support organization build and ramp-up of clinical production and facility approval of a state-of-the-art cell therapy facility… more
- Catalent (St. Petersburg, FL)
- … control, manufacturing, product development preferred (Feasibility Batches, Clinical , Registration, Product Transfer)Proven ability to multi-task and demonstrate ... Manager, QA (Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership...the clients with products that have technical opportunities for improvement . The QA Manager will act as an initial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Job SummaryThis position is responsible for clinical label development support for all Daiichi-Sankyo led clinical ... with the CSO Program Managers to identify and meet delivery dates for clinical labels to our CMO's and internal packaging sites for GMP processing operations.… more
