- Merck & Co. (Rahway, NJ)
- …Assurance Services' (MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ... divisions and functions to evaluate the adequacy of internal controls and deliver audit reports that add value to the area audited.Coaches, mentors and trains staff… more
- Merck & Co. (Rahway, NJ)
- …and Assurance Services primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ... ResponsibilityUnder the direction of the Client Audit Director ("CAD") and the Auditor-in-Charge ("AIC"), the Senior...with limited management supervision in addition to actively performing audit work.Under the direction of the AIC, partner with… more
- Insmed Incorporated (NJ)
- …Officer, the role will be responsible for developing and executing a comprehensive risk -based audit plan, while providing independent and objective assurance and ... audit function, developing and executing on the annual risk -based internal audit plan.Lead the full compliance program with Sarbanes-Oxley (SOX) Section 404,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems as applicable for the area of GxP audits assigned in alignment with the Master Audit Schedule using a risk -based approach to ensure the Audit Plans ... The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Manager of Treasury and Risk Management monitors and updates various cash flows and procedures, including domestic and ... debt and investment instruments. The Manager of Treasury and Risk Management assumes responsibility for corporate cashiering, accounts-receivable deposits,… more
- Jazz Pharmaceuticals (San Jose, CA)
- …the Senior Manager, REMS Data Programmer will provide support for FDA mandated Risk Evaluation and Mitigation Strategy (REMS) programs and other patient and product ... risk management initiatives. This role reports to the Associate...solutions align with business requirements and stakeholder needs. Ensure audit preparedness and support regulatory inspections for REMS. Support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …all sites.Manage and support the implementation of the internal and external audit program.Schedule, execute, report and follow-up on internal and US and Global ... external audits (travel required).Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and procedures as well as… more
- Vaco by Highspring (Boston, MA)
- …is going through tremendous growth. Global organization About the Opportunity Conduct risk -based audits, document and report audit results in accordance with ... is going through tremendous growth. Global organization About the Opportunity Conduct risk -based audits, document and report audit results in accordance with… more
- Merck & Co. (Durham, NC)
- …and procedures.Perform shift work as needed.May act as a Quality Risk Assessment Lead.Skills Education Minimum Requirements:High School Diploma or equivalentRequired ... Review, Driving Continuous Improvement, Environmental Monitoring, GMP Compliance, IS Audit , Multidisciplinary Collaboration, Problem Solving, Process Improvement Projects, Process… more
- Merck & Co. (Rahway, NJ)
- …and ensure team and company adherence to these documents.Develop a risk -based approach to prioritize USDA compliance requirements for our manufacturing ... guidelines, customer requirements, SOPs and project specific guidelines/ instructions.Evaluate audit findings and ensure timely identification/ escalation of potential… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for case-related ... metrics to ensure departmental KPIs and regulatory compliance are consistently met Audit & Inspection Readiness Support the preparation and execution of internal and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …programs.Partner with Medical Affairs to facilitate the implementation of a risk -based quality management process fully embedded through trial design, execution and ... Affairs team, ensuring collaboration with other GxP QA functions (eg, GMP/IMP QA, Audit and Compliance, QMS QA, Development QA, and PVQA) to address GxP-related… more
- Aequor (Thousand Oaks, CA)
- …Digital QMS platform for health and control processes. Leads Digital QMS audit & inspection readiness, deviations and change control activities Manage Organizational ... professional journals, technical procedures, or governmental regulations Experience with risk -based Supplier Quality Management process. Management of Global Inspection… more
- Cipla (Reid, WI)
- …deviations. Develop, implement and assess solutions for complex problems. Anticipates risk and builds contingencies to help mitigate impact. Reviews document for ... of BMR and eBMR. Knowledge of p reparation of SOP and eLog books. During audit part of team. Planning of batches as per production plan. Knowledge of audits and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …practices, foster a culture of continuous improvement in benefit- risk evaluation, and participate in inspection readiness activities.Responsibilities:This individual ... if applicable, proposed actions (eg, changes to product information and/or other risk minimization measures) as a result of a validated signal.This individual will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …external vendors/contractors Ensure seamless operations and timely delivery of safety data Risk Management Act as the primary point of escalation for Medical ... audits and regulatory inspections Ensure documentation and processes are audit -ready and aligned with global pharmacovigilance standards Physical Requirements 0-10%… more
- Insmed Incorporated (NJ)
- …partners. The position is critical in shaping quality strategy, managing risk , and supporting regulatory readiness for complex, evolving pipelines.What You'll Do: ... critical CDMOs and service providers.Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate… more
- Insmed Incorporated (NJ)
- …Engineer will partner with IT, business, and vendor teams to apply risk -based approaches, maintain validated state, and drive continuous compliance in support of ... Process such as Change Control, Deviation, CAPA, Supplier Quality, Internal/External Audit , Quality Complaints and Production Process Control.What You'll Do: Provide… more
- DWS Group (New York, NY)
- …and efficiency. Successful relationship and interactions with Operations, Technology, Compliance, Risk and Audit . Your Skills & Experience: Proven trading ... experience in a buy-side or sell-side environment, covering Structured Finance products including ABS/CLO/Non-agency MBS. Strong analytical, communication, and collaboration skills, with the ability to engage effectively with internal teams and external… more
- Insmed Incorporated (NJ)
- …objectives that will support the strategic business plan of the company.What You'll Do: Audit & Compliance Support: Assist in preparing documentation for SOX and IT ... Business, Computer Science, or a related field.Interest in IT governance, risk management, compliance, and business applications.Familiarity with ERP or HCM systems… more
