- Novo Nordisk Inc. (Plainsboro, NJ)
- …their expectations. Quality Assurance Provides secondary support to all USO Quality Management processes, including but not limited to Product Disposition ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR... management of contingent workers. Essential Functions Deviation Management Acts in role of Quality Assurance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety Management to ensure timely ... and Compliance, Global Safety, and centralized teams (eg, Training and Documentation, Quality , Supplier and Contract Management and Digital Enablement). This… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....make a difference? The Position To ensure oversight and management of all contract and vendor related activities in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …system change control, validation, and upgrade activities Governance & Change Management Support Safety/ Quality /Training leadership in operational and governance ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and works cross-functionally with internal departments on Regulatory Affairs related issues . Essential Functions With direction from management participates on ... emerging issues and proactively developing solutions. With direction from management participates in FDA and HC submission planning meetings to ensure clear… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders to proactively identify and mitigate potential issues Compliance & Quality Assurance Partner with NNI Patient Safety Management to ensure timely ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Serve as Technical Complaint Processing Team's safety system manager Oversight of quality management : Facilitates and/or participates in regularly scheduled call ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high-risk supplier contracting. ... Provide Strategic Legal Counsel Interpret complex internal and external business issues related to contracting and recommend best practices and solutions Proactively… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming ... reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.Oversees the execution of external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the drug development process.- Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and ... to ensure data quality /integrity and regulatory compliance- Ensures that Data Management Plans are consistent and regulatory compliant across studies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contract quality and adherence PV Regulatory Intelligence: Oversees the Management of PV Regulatory Intelligence and dissemination across CSPV stakeholders for ... the key DSI contact for PV service providers to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations and root cause analyses on any supply disruptions or material quality related issues .Support Quality , Regulatory and Financial audits.Provide ... accuracy and compliance by maintaining Info records, source lists, material management , RFQ and contracts.Meet assigned data maintenance timelines and special… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …maintaining compliance and quality .Must be able to discern the criticality of issues and to communicate to management regarding complex issues .Ability to ... inspection readiness within facility.Perform internal housekeeping audits.Perform analysis on quality indicating data and identifying trends.Provide oversight… more
- Merck & Co. (Rahway, NJ)
- …Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements ... GMP Auditing, GMP Compliance, GMP Operations, Good Manufacturing Practices (GMP), Inspection Readiness, Quality Auditing, Quality Management , Quality … more
- Formation Bio (New York, NY)
- …the product development lifecycle. Ensure the timely and effective resolution of quality issues and deviations, working collaboratively with internal and ... and sites, providing support during health authority inspections, and offering guidance on quality issues . Ensuring vendors adhere to relevant quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of cell therapy manufacturing. This includes hiring, development and performance management of staff, reviewing/approving laboratory test data , developing and ... of multiple myeloma.Legend Biotech is seeking Supervisor, QC Micro as part of the Quality team based in Raritan, NJ. Role OverviewThe Supervisor, QC Micro is an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to ... standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance,… more
- Merck & Co. (Rahway, NJ)
- …Content Management , Content Management Systems (CMS), Cross-Cultural Awareness, Data Management , Data Quality Assessments, Documentation Review, ... questions and issues related to submission content management , quality and standards complianceEngage across functional...process requirementsDevelop and evaluate metrics as part of a data quality monitoring plan to determine where… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible in handling day-to-day activities inclusive of execution, protocol management , vendor management , issues , deviations, corrections and ... outside contractors/vendors to complete tasksSupports and/or owns technical and quality investigations, CAPAs and correctionsDevelops and performs any required… more
- Terumo Medical Corporation (Somerset, NJ)
- …The Sr. Clinical Quality Specialist collaborates cross-functionally to resolve complex quality issues , develop quality metrics and dashboards, and ... escalation for clinical suppliers Advising clinical teams on handling noncompliance and quality issues during study execution Collaborating with stakeholders to… more
