- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Tris Pharma (Monmouth Junction, NJ)
- …guidelines, standards and objectiveOversees and manages maintenance and tracking of Quality Systems including, but not limited to: Investigations/OOS/OOT/Lab ... and product quality complaintsEngages in activities to continuously assess/improve quality systems by identifying and proactively resolving quality … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global ... study level.- Proactively identifies and manages risks to data quality and/or timelines at the study level and escalates...study level and escalates issues to the DM program lead .- Will manage DM resources of assigned studies; provides… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and ... requiring MES enhancements.Coordinate MES updates with other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …programsAssists in the creation, tracking and completion of metrology related SOPs, quality events, CAPAs, Out of Tolerance (OOT) situations and other technical ... provide start-up, commissioning, and qualification/validation support of instrumentation and systems including on-the-floor troubleshooting of equipmentPromotes a collaborative work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …help the team, in a manner consistent with safety policies, quality systems , and cGMP requirements.Support manufacturing investigations, create/revise ... a team-based environment, on an assigned production shift schedule.Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cost savings, and deliver measurable value through sourcing excellence.Key Responsibilities Lead and support implementation of a Global Sourcing organization for all ... process and periodically update risk score of all BOM and other high-risk Materials. Lead development of Sourcing Score Boards, KPIs and other Metrics to create… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is develop strategic framework work for GxP ... across DS group including business units, functional units and corporate functions. Lead Training function team and Document and record management function team… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Novo Nordisk US Operations (USO) AI Center of Excellence (AI CoE). The individual will lead and manage a team of data and AI engineers and developers and is tasked ... cutting-edge AI/GenAI technologies and developing AI/GenAI products to deliver high quality insights with speed and efficiency Promotes a culture of creativity… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …Associate, Quality Investigations in our Princeton, NJ office. This role will report to Lead Quality Systems . The Lead Associate, Quality ... Data Review controls and improvement efforts across the North America region. + Lead and conduct detailed quality investigation reviews and approvals related to… more
- GAF (Trenton, NJ)
- … the development, implementation, maintenance, and reporting of GAF Quality Management Systems within Supplier Quality .* Lead the development and vetting ... towards enforcing, enhancing, and optimizing specifications, industry regulations, and GAF Quality Systems to uphold product standards and operational… more
- Verint Systems, Inc. (Trenton, NJ)
- …responsible for the design, development, and the implementation of server-side software systems . The Team Lead leads the design, development, testing, ... opportunities. Learn more at www.verint.com . **Overview of Job Function:** The Team Lead , Software Engineering works in a software development team with members of… more
- WSP USA (Lawrenceville, NJ)
- …Opportunity WSP USA is initiating a search for a Full-time **Electrical/ Critical Systems '** ** Lead Commissioning Agent** for our **New York** office. Other ... to validate construction, integrity, operability, and the commissioning of systems and facilities projects in the public and private...are delivered and adhered to with a level of quality that meets or exceeds acceptable industry standards for… more
- Lumen (Trenton, NJ)
- …Join us as we digitally connect the world and shape the future. **The Role** Lead a portion of a program effort to translate the client's business requirements into ... specific data systems , applications, or process designs and deliver innovative business...plans and related policies and procedures + Takes a lead role in establishing and implementing standards that will… more
- BeOne Medicines (Pennington, NJ)
- …quality functions and provide technology leadership and governance support for the Quality organization. The individual will lead the GTS strategy and provide ... of working. The individual must ensure reliable deployment and operations of all Quality (QA & QC) platforms & systems for commercial manufacturing facilities.… more
- Integra LifeSciences (Princeton, NJ)
- …advance patient outcomes and set new standards of care. As part of Integra's Business Systems Team, the Quality Systems Senior Specialist is a seasoned ... device industry. 4-5 years of proven experience in an analytical or business/ quality systems environment. + Technical knowledge of Trackwise Digital system… more
- EPAM Systems (Newtown, PA)
- As a ** Quality Architect** within EPAM's Testing Practice, you will play a pivotal role in designing and implementing advanced quality assurance strategies for ... (RAG) frameworks. Your expertise will empower clients to achieve high- quality software releases with optimized efficiency and innovation, ensuring alignment… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Director, Quality Management System is responsible for standardization and proactive compliance of Amneal's QMS with the worldwide drug, biologics ... This role is responsible for compliance monitoring, compliance risk identification, quality plan for new requirements, site inspection readiness, and regulatory… more
