- 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)
- …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
- Integra LifeSciences (Plainsboro, NJ)
- …7 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP's), and Health and Safety ... for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring weekend (Friday… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and establish transition activities and responsibilities for Legend.Key ResponsibilitiesServes as the Quality Lead in support of cell therapy manufacturing and ... team based in Raritan, NJ.Role OverviewThe Sr. Director of Quality will lead Legend CAR-T manufacturing facilities...exceptional team to manage the Quality functions ( Quality Assurance, Quality Systems , … 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
- Formation Bio (New York, NY)
- …them for regulatory inspections. Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …labels, shippers, displays). + Experience with cGMP's, all applicable FDA guidelines and Quality Systems . Prefer additional understanding of ISO, USP, ISTA, ASTM ... options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready… 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 ... records and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead the daily start of shift operations meetings, the daily wrap up… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …on Market Access and pricing related agency selection and management, ensuring the highest quality of collaborations at proper cost. + Lead in Integrity: Ensure ... value proposition of Sun Pharmas products to Global payer systems with specific focus on US, Europe and Japan....focus on US, Europe and Japan. This individual will lead pre-launch and launch strategic planning and execution to… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …products. Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to more than ... closely with key stakeholders including, but not limited to DEA, Operations, and Quality in coordinating the daily functions of the security department to ensure… 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)
- …and problem solving program to improve safety, compliance, cost, process stability building quality and efficiency into processes to improve lead times and ... cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to support of… 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
- 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 ... execution.Knowledge of LMS system.Supports the maintenance and reporting of quality training metrics.Support daily manufacturing activities when necessary. RequirementsA… 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
- 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
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …equipment issues promptly. + Revise methods and procedures to improve efficiency and quality . + Utilize systems such as **SAP, TrackWise, EDMS, and ... products** . Supported by more than 40 manufacturing facilities, we provide high- quality medicines trusted by healthcare professionals and patients in over 100… more
- BeOne Medicines (Pennington, NJ)
- …laboratory daily workflow. + Establish and maintain QC Physicochemistry laboratory related quality systems to ensure conformance with regulations and BeOne ... **General Description:** Manages all Quality Control (QC) Physicochemistry laboratory activities to support...Global quality standards. + Manage QC Physicochemistry laboratory routine operations,… more
