- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Quality Systems Lead role as part of the Quality Operations team ... based in Raritan, New Jersey. Role Overview The Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality … more
- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty and the Oncology ... Business Unit globally; promote a quality culture within Global Medical Affairs Quality ...as applicable. Support MA/PV health authority inspections with adequate systems and process support, including facilitation of respective regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all Global Oncology Medical Affairs (GOMA) Company Sponsored ... clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, and relevant ICH/GCP Guidelines Review protocols to ensure designs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency and quality of data across key Daiichi Sankyo regulatory systems . This includes defining regulatory data standards, data quality rules and ... areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse...the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP and Non-GxP activities, assuring that these systems ... Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in partnership with Global DX, and QA-CSV/eCompliance team members… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryAs a Manager , Generative AI, you will be responsible for conceptualizing, developing, implementing, ... the team has the necessary tools, infrastructure, and support to deliver high- quality AI solutions. Provide mentorship and guidance to individuals and teams on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development and implementation of new processes, procedures and/or systems to improve organizational efficiencies and cost controls.Communication and ... strategy by spend category that reduces costs, reduces timelines and improves quality . Coaches and mentors' colleagues on the outsourcing process and procedures.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... maintenance of the GCO training curriculum in collaboration with Clinical Quality Management and/or QA, as appropriate.-Participate with the identification and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and curricula development experience including oversight and administration of validated electronic systems such as LMS or other quality management systems ... or Global project teams. This position has advanced skills in technology systems , including word processing software and data management software, and business… more
- Merck & Co. (Rahway, NJ)
- …at least 2 years of direct experience with developing and managing clinical quality systems and management of regulatory inspections.Knowledge and background in ... Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable for...clinical development programs, clinical trial processes as well as quality management systems and quality … more
- Merck & Co. (Rahway, NJ)
- …modalities. We are interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with our partners in ... so everyone can bring their whole self to work.Within DSCS, the Digital Program Manager will advance the purpose and aspiration of our Company 's DSCS Digital… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... define priorities.Anticipate upcoming tasks based on the submission timelines.Perform quality control checks and coordinate comment resolution with publishing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a lower complexity or regional project or be partnered with a more senior project manager in support of a larger, more complex drug development project. As a project ... manager this position is accountable for partnering with the...the organization.Manages project status in the project management information systems and communicates risks/issues to GPM senior management in… more
- Aequor (New York, NY)
- …Minimum experience of 1-3 years in case management, utilization review and/or quality assurance Experience in episodic care, wellness care and counseling of adults ... Proficiency in use of electronic medical record keeping systems desirable BLS certification required Optional: Case Management and COHN-S certifications Major… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …simultaneously Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements. Drive continuous improvement Other duties ... of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview The QA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Manager , NextGen Customer Engagement will support Novo Nordisk's strong commitment to its customers ... responsible for agile execution and support of new capabilities, platforms, and systems within Novo Nordisk in partnership with internal stakeholders and external… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD). Manages mutually… more
- Merck & Co. (Rahway, NJ)
- …Engineer will be responsible for evaluating, recommending, implementing and supporting systems in the manufacturing and lab print environment including label and ... perform lifecycle management of bar code printers and software systems . The engineer will also look to strengthen the...operations.The engineer will also work with the Print Product Manager to adopt and set a vision, roadmap, manage… more
