- 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
- Bayer (Whippany, NJ)
- …difference, there’s only one choice. Senior Director, Digital Governance & LMR Lead The Senior Director, Digital Governance & Legal Medical Review (LMR) supports ... teams to be accountable for the delivery of high quality , ethical standards of service. The role combines digital...of this role, Senior Director, Digital Governance & LMR Lead , are to: Oversight of External Communication Procedure: Acts… 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
- Merck & Co. (Rahway, NJ)
- …of 6 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area. Strong knowledge ... Job DescriptionThe Senior Scientist, Device Risk Management Lead , is a crucial member of our team,...device risk management activities to ensure the delivery of high- quality products and efficient manufacturing processes. The role requires… 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
- ValSource, Inc. (Rahway, NJ)
- …projects directly at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves ... currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Packaging Procurement Director is responsible to lead the Packaging Center of Excellence (COE) organization. The scope for this role ... Annual spend in this category is more than ~$200M, and delivery of high- quality procurement performance and capabilities is expected as part of our Company's global… more
- Merck & Co. (Rahway, NJ)
- …initiatives. You'll reduce manual reporting through automation, improve decision speed and quality , and help the team adopt data-driven ways of working, translating ... insights into realized savings.-What you'll do: Lead feasibility analysis for automation and analytics opportunities-frame the business problem, quantify potential… more
- Merck & Co. (Rahway, NJ)
- …SOPs for all GxP automation systems . Lead integration of control systems with MES, Quality , and Batch Reporting applications.Understand and adhere to CFR, ... improvements, etc.), changes to support new products, and maintaining the automation systems in compliance with cGMP- Lead automation related investigations into… more
- Merck & Co. (Rahway, NJ)
- …role involves leveraging your expertise in packaging, particularly in thermal protection systems and in distribution testing. We value the application of sound ... with experienced supervisors who provide valuable guidance while you lead projects from conception to implementation.Primary responsibilitiesLead the development and… 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 ... curriculum in areas of general use, foundational and core skills, systems , unit operations and aseptic processingPrepares and maintains training lab, materials… 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)
- …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
- 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
- Merck & Co. (Rahway, NJ)
- …and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality , and Supply Chain from early development through to commercial ... and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of… more
- Merck & Co. (Rahway, NJ)
- …control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
