- Legend Biotech USA, Inc. (Raritan, NJ)
- …Manufacturing Execution Systems Lead and will be responsible for providing project management support to the development and administration of EBR and digital ... CMC, and IT. This individual will be responsible for management and delivery of the project plans for electronic...for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan, NJ.Role OverviewThe position will be part of the integrated CMO virtual management team working with our partner JNJ, to oversee the day-to-day business ... Quality and the CMO teams to collaboratively drive the deliverables and timelines.Conduct risk and gap analysis, maintain risk registry and develop mitigation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a ... Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …goals. The Manager will play a key role in vendor management , contract negotiation, and operational procurement excellence.Key Responsibilities Support and lead ... not limited to:Materials: Lab supplies, PPE, MRO, etc.Services: Facility management , logistics, calibration, waste management , etc.CapEx: Equipment purchases,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and budget related activities.Process-oriented with strong analytical skills for risk identification and management .Ability to translating complex analytics ... Power BI to support FP&A deliverables such as KPI reporting, monthly management reporting, budget vs. actuals (BvA), rolling forecast analysis, and long-range… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …environment.Learn new skills, procedures and processes as assigned by management and continue to develop professionally.Support and contributes to projects.Assist ... effectively determine appropriate resolutions that ensure compliance and minimize risk .Ability to collaborate well with stakeholders, customers and peers.Must… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …enhancement and Global harmonization of the supplier qualification program, including management of the electronic systems for this program.Work with External ... and other internal functions to understand and mitigate any compliance risk and establish vendor quality scorecard.Support development and gathering of quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues resulting ... effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and effectively develop others.Ability… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues, deviations, corrections and remediation ... review of change controls, SOPs, and other documentationParticipates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …changes to the same and their impact on the Carvykti product. Stakeholder management is required to drive and implement documentation template efforts worldwide as ... as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and effectively develop others.Ability ... be able to discern the criticality of issues and to communicate to management regarding complex issues.Ability to manage conflict and issues that arise with internal… more
- Merck & Co. (Rahway, NJ)
- …through commercialization and post- market evaluation.Develop and execute the device risk management strategy, including the creation of device risk ... Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial...and external sites ensuring proper translation and implementation of risk control measures.Analyze information from post- market surveillance,… more
- Bayer (Whippany, NJ)
- …and configuration of AI including implementation of controls. Performs a formal risk assessment based upon the intended use and configuration of AI. Reviews ... the testing/validation of AI. Prepares an AI risk mitigation plan (as needed). Enforce relevant QSDs/LQSDs, documentation...support as needed to the US Partnering & Issue Management organization team-mates on Medical Governance and other relevant… more
- SMBC (New York, NY)
- …Risk Management Department Americas Division (RMDAD). The VP understands Market Risk management fundamentals, financial products, and their associated ... administration, or related field Minimum of seven years' experience working in a Market Risk management role Understanding of risk management … more
- Prysmian (Bridgewater, NJ)
- …levels established by Prysmian and the customer. As part of the Bridgewater Management Team, the Quality Manager is also responsible for ensuring the plant meets ... the Quality System + Supports the Safety and Environmental Management System. + Interaction with customers on various product,...technical nuances of the oil and gas, and downhole market (s). + Interacting with North America HQ personnel for… more
- Merck & Co. (Rahway, NJ)
- …and supporting continuous improvement initiatives related to design control and risk management processes for combination products. This includes identifying ... of device development strategies and drive continuous improvement in design control and risk management processes. This individual will be expected to apply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and cross-therapeutic applications Guide rigorous feasibility and viability assessments (SWOT, risk assessments, financial models) to validate market fit and ... that focus on delivering on consumer needs/expectations, maximize near term market potential and improve patient and HCP experiences. Use rigorous feasibility,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …guidelines (in collaboration with legal counsel). Develops solutions which mitigate NNI's risk while ensuring NNI can maintain market access via contracting ... and pricing of Novo Nordisk products. Works closely with Market Access account teams to secure access for NN...Works closely with senior level partners in field Account Management across channels (Institutional, Rare Disease, and Area Accounts)… more
- Merck & Co. (Rahway, NJ)
- …its customers, and shareholders. The scope of this group includes strategic program management , enterprise strategic planning, risk management , as well as ... ideal candidate will possess innovation, insight, commercial acumen, and broad market perspectives to provide commercial strategy expertise for our company.… more
- Terumo Medical Corporation (Somerset, NJ)
- …information provided. - Familiarity with relevant regulations, compliance standards, and risk management practices. - Ability to drive continuous improvement ... for products and services through effective bidding, negotiation, and supplier management . This position requires an understanding of the technology life cycle,… more
