- 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
- 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
- Merck & Co. (Rahway, NJ)
- …our patients, partners, and colleagues.As a Technical Product Manager for the Compliance, Risk, Quality , & Vendor Management product you will spend a lot of time ... across the organization. Candidate will be accountable for the entire Compliance, Risk, Quality , & Vendor Management product from the prioritization and roadmap… more
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …and logistics to support manufacturing operations while partnering with Manufacturing, Quality , Sales, Marketing, and Finance. Leads the monthly S&OP processes ... * Oversee the timely validation, analysis and publishing of operational data and executive-level reports that monitor end-to-end supply chain performance against… 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
- 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
- ValSource, Inc. (Rahway, NJ)
- …Part 11 compliance and latest industry expectations for data integrity. Project Management experience in managing scope, cost, schedule, quality , and risk is ... Requirements Minimum of 7 years’ experience with increasing responsibility in validation/ quality service and project management of life sciences, biotech… more
- Merck & Co. (Rahway, NJ)
- …the team alignment with functional objectives.Ability to communicate program progress, issues , and mitigation plans to the senior management .Innovative mind-set ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Merck & Co. (Rahway, NJ)
- … Process, Preparation of Financial Reports, Procurement, Project Human Resource Management , Project Management , Quality Standards, Report Writing ... will be expected to lead small teams of auditors audits with limited management supervision in addition to actively performing audit work.Under the direction of the… more
- Merck & Co. (Rahway, NJ)
- …Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Research Management , Clinical Studies, Clinical Testing, Clinical Trials, Data ... Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new… more
- Merck & Co. (Rahway, NJ)
- …excellence in support of the portfolio of work, including interrogation of the data / science through technical reviews and exploring alternative ways to view and ... introductions and technology transfers across the network.Drive proactive risk management activities, including risk assessment, risk mitigation, and risk… 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
- Merck & Co. (Rahway, NJ)
- …teams. Problem Solving: -Remove roadblocks, resolve conflicts, and escalate issues when needed. Communication: -Foster collaboration, ensure transparency, and engage ... governance bodies. - Excellent interpersonal and communication skills Project Management : -Drive project schedules, set clear priorities, and monitor performance… more
- 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
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implementing study/program-specific quality plans for proactive quality management .Collaborate with the audit function, Data Management teams, MA ... Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial...stakeholders and CROs to ensure high data quality , proactively identifying and resolving issues throughout… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Management :Develops talent through providing focused career development, performance management and manages retention.Fosters a high- quality culture ensuring ... immune disorders. Job Summary: Provides operational oversight to study management personnel within assigned program(s). Provides managerial oversight to colleagues… more
- Eisai, Inc (Nutley, NJ)
- …and inspection management , issue management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) ... inspection management , issue management , and oversight of the quality management system).Conduct complex audits of sites, vendors and internal… more
