- Legend Biotech USA, Inc. (Raritan, NJ)
- …based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and ... Deviation Investigations: Collaborate closely with the Quality Associate Director to co- lead the deviation investigations management system. Ensure alignment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk Must exhibit strong leadership skills and ... multiple myeloma. Legend Biotech is seeking a QA Investigations Lead (2nd or 3rd shift) as part of the...high quality and complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with… more
- Insmed Incorporated (Bridgewater, NJ)
- …matrix organization, driving decision making, facilitating issue resolution, problem-solving, risk management , contingency planning and decision-making. Lead ... processes. This position will be accountable for all necessary strategic planning, risk management , operational execution and communication required for the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management sciences, and risk management tools and resources.- Risk Management Compliance Inspection Readiness Champion. Serve as member of ... management aware of any gaps in risk management planning, creation, and execution- Lead /Manage RMP initiatives. Lead and/manage RMP initiatives and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …issues. Review critical level investigations and supporting corrections and CAPAs. Lead continuous improvement associated with investigation management . Support ... able to interpret problems and effectively determine appropriate resolutions that ensure compliance and minimize risk . Must exhibit strong leadership skills and… more
- Insmed Incorporated (Bridgewater, NJ)
- …and QC validation documents.Preferred ASQ CQE and CQA Certifications.Medical device and Risk Management experience preferred, ie ISO 13485 and ISO ... Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director, Quality Operations will play a key role in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Possess the ability to positively influence peers, key stakeholders and management . Generates shift schedules, to ensure efficient coverage for all operational ... and preventive actions, as necessary. Supports internal/external audits. Supports Quality risk assessment teams. Review/approve documents as a Quality on the Floor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing). ... expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with other Leadership Team members to optimize processes, resource allocation, and risk management strategies leveraging project management tool ... Head of Centre for RWD / RWE (CR2) Project Management and Operational Excellence (PM-OE) will lead ...and track the hiring timeline according to plan, identify risk or gap for timely escalation and develop contingency… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor selection process in collaboration with the study team and outsourcing procurement management . Lead the creation of the CRO scope of work in collaboration ... with Outsourcing Procurement Management . Lead trial feasibility and site identification activities...and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …has strong skills in continuous improvement, project management , change management , and risk management . ResponsibilitiesLeadership, Direction, and ... effectiveLeads functional and/or multidisciplinary teams working on projects/studies and/or initiatives. Lead and manage the standardized Data Management Process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor selection process in collaboration with the study team and outsourcing procurement management . Lead the creation of the CRO scope of work in collaboration ... with Outsourcing Procurement Management . Lead trial feasibility and site identification activities...and relevant governance bodies.Triage, resolve or escalate study issues / risk mitigations to the Operations Program Lead … more
- Merck & Co. (Rahway, NJ)
- …high performance motivated global teamProcess - Realize mature SAM services, supplier value management , risk management , as core sustainable processes and ... the hybrid team, including activities such as:Operational: software license compliance , software audit preparation, entitlement management , software asset… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …require strong skills in continuous improvement, project management , change management and risk management .Responsibilities Project level AI/ML ... direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, policies,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position will require proven skills in continuous improvement, project management , change management , and risk management . The position will act as main ... matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as… more
- Merck & Co. (Rahway, NJ)
- …IT organizations to ensure alignment with Platform teams, IT architecture, IT Risk management , support organizations in delivering projects.Contribute as a ... and build key relationships with the Finance Value Team Lead , and the Tax Management Product and...as OneSource, Vertex, SAP Tax, Ariba Tax, Concur Tax, Compliance and VAT reporting and the core business processes… more
- Merck & Co. (Rahway, NJ)
- …state business objectives.Within the EIT SAP Platform Team, the Financial and Budgeting lead will have responsibility to track and manage TCO (Total Cost of ... related to project execution and closeout.- The incumbent will also lead the contracting/PO process for goods (software/product licenses) and services procurement,… more
- Merck & Co. (Rahway, NJ)
- …Code of Conduct and the Ethics Ambassador Program, developing ethics and compliance training workshops and communications, and managing other key initiatives in ... candidate's ability to work effectively with colleagues within the Ethics and Compliance Office (ECO) and across divisions, functions, and regions. This position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Site Reliability Engineer (SRE) Architecture Lead , you will drive the technology strategy, architecture, and operational excellence of critical ... key responsibilities of the Site Reliability Engineer (SRE) Architecture Lead , highlighting their role in driving technology strategy, implementing SRE… more
- Merck & Co. (Rahway, NJ)
- …responsible to support the operational functions of the Third Party Quality Management group, which provides quality oversight of suppliers and GMP service providers ... profiled and platform vendor base,Operational execution for phase appropriate, risk based processes for third parties' performance oversight and monitoring,Support… more
