- 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
- BeOne Medicines (Pennington, NJ)
- …BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead the site drug product MST function to support technology transfer, validation, ... as MST DP Subject Matter Expert (SME) and process lead for drug product, ensuring the materials, strategy and...Qualification & Validation + Equipment and/or Process Design + Quality Risk Assessments + Health Authority Interaction/Audits + OE… more
- BeOne Medicines (Pennington, NJ)
- …ensuring they are delivered on time, within budget and to the required quality standards. + Process Optimization - Identify high-volume or error prone processes ... related to cell culture, purification, filling, packaging and OSD. + Participate and lead in controls fault or process fault analysis and remediation. + Vendor… more
- BeOne Medicines (Pennington, NJ)
- …laboratory through late phase activities. + Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global ... quality standards. + Supervise a highly efficient QC Biochemistry...cGMP/EU GMP regulations. + Direct experience in a GMP quality control lab is a must. + Familiar with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OOS monitoring and trending program)Contribute to developing and/or improvements to quality systems in support of global implementation of changes ... initiatives.Experience in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive… 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 ... Vendor Oversight. This job will interact with Patient Safety, Quality , Vendor and Contract Management, IT, Finance, Contract/Supplier of...Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …sites, internal GMP (Good Manufacturing Practices) departments, external partners, and quality systems for ensuring compliance with regulatory requirements and ... You will be responsible for conducting thorough assessments of potential vendors' quality systems , capabilities, and processes to ensure alignment with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within budget, per direction, and are internally consistent with group deliverable quality Systems and Data Management Responsible for gross-to-net forecast ... customer alignment as necessary. The position is responsible for: Lead support for development of gross-to-net forecasts for Rare...and evolving business needs Continuously reviews and evaluates the quality of data and new data sources used in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …part of Manufacturing Science and Technology team reporting to the Manufacturing Execution Systems Lead and will be responsible for providing project management ... The major responsibilities will include but are not limited to: Lead project core teams to ensure on time project...deliverables for MES and/or digital projects and ensures that quality , risk, cost, time are managed within the overall… more
- Integra LifeSciences (Plainsboro, NJ)
- …new treatment pathways to advance patient outcomes and set new standards of care. The ** Lead Quality Inspector** serves as a Lead Associate, Quality ... using electronic document storage. + Minimum of 5+ years' experience in a Quality Systems / Regulatory Compliance environment with a working knowledge preferably… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …ensures that the manufacturing building, relevant campus infrastructure, equipment, and systems support business goals and comply with safety, regulatory, and ... response to unexpected issues are critical for this leader.Key Responsibilities Lead and oversee all engineering management including asset/reliability, data … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Calibrations are scheduled, completed, and properly documented with supporting records attached. Lead the Building and Environment monitoring team to ensure the ... control and update / communicate with all teams with any emergencies and disruptions. Lead the maintenance and metrology support specialists to ensure all vendors for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equipment and capital expenditures (CapEx), ensuring alignment with business objectives, quality , compliance, and cost optimization. The role will work closely with ... cross-functional stakeholders including Manufacturing, Facilities, Maintenance, Engineering, Quality , Finance, Supply Chain and Global Procurement to meet site and… more
- Parexel (Trenton, NJ)
- …project leadership? Parexel is seeking a dynamic **Patient Safety Project Lead (PSPL)** to spearhead high-impact safety initiatives across full-service, functional, ... with hands-on leadership, driving client satisfaction, optimizing resources, and ensuring top-tier quality and compliance in every facet of patient safety. As a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of ... executionKnowledge of LMS systemSupports the maintenance and reporting of quality training metricsSupport daily manufacturing activities when necessaryRequirementsA minimum… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supply Chain team based in Raritan, NJ. Role OverviewThe Site Supply Chain Lead will be part of the Manufacturing Technical Operations team responsible for leading ... will partner with the plant leadership team, various Technical Operations and Quality functions to support both clinical and commercial manufacturing operations, in… more
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …achieving process improvements and associated operating efficiencies * Familiarity with Quality systems and compliance expectations across geographies. Able to ... and logistics to support manufacturing operations while partnering with Manufacturing, Quality , Sales, Marketing, and Finance. Leads the monthly S&OP processes… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …various Technical Operations groups [e.g., Operations, MS&T, Supply Chain, etc.] and Quality functions to lead all planning and detailed scheduling activities ... efficient scheduling of equipment PMs & Cals while supporting manufacturing plan. Lead material allocation improvements and other optimization projects.An ability to… more
- SCRAM Systems (Trenton, NJ)
- …will focus on content, communications, and marketing automation to deliver consistent, high- quality experiences across the SCRAM Systems family of brands, ... reminders, renewals, and re-engagement? + Support segmentation, personalization, and lead -nurturing strategies across multiple audiences (consumers, affiliates, attorneys, and… more
- Parexel (Trenton, NJ)
- **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote (US based) Must be able to accommodate West Coast hours. **About Us:** At ... We are seeking a dynamic and experienced Data Management Lead to join our team. If you have a...practices for data collection, propose innovative solutions, and ensure high- quality , compliant data. + Use surveillance tools to review… more
