- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Technical knowledge in maintenance/metrology management , broad understanding of facilities management , cGMP compliance , EHS and regulatory standards (eg EPA, ... Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and operating… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations and be responsible for the ongoing site ramp-up, daily operational management , as well as continuous improvement of cGMP Warehouse Operations within a ... safe and compliant operations according to cGMP requirements. Major Responsibilities Lead , direct, coach, and develop an effective Warehouse Operations team… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … and compliance standpoint and establishes a comprehensive interface for risk and issue management with strategic development partners.Close partnership with ... (SMEs), and other functional area partners to ensure GCO risk management activities are executed and continuously...clinical quality management and other compliance functions within and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Action (CAPA) plans and related effectiveness measures, as appropriate.Responsibilities:Clinical Trial Operational Risk Management :Own, lead and manage GCO ... and compliance standpoint and establishes a comprehensive interface for risk and issue management with strategic development partners.As needed, involved in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible to support ... next steps for strategic process update and/or information sharing.Responsibilities:GCP Compliance :Develop seamless partnerships within GCO and non-GCO functions to… 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)
- …Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management , will be accountable for the authoring and lifecycle management ... GCP standards. The Associate Director will also be responsible for the creation, management , and documentation of GCO's CRO SOP review and maintaining the master… 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)
- …and along the GvP modules in support of a proactive quality risk management process.Interact with the audit and compliance function for the development of ... in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, compliance , and inspection preparedness for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all ... as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated...Daiichi Sankyo's quality measures. Leads the creation of the Risk Identification and Management Log (RIM Log)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …deliverables are met. The key responsibilities are within and for GCO to: 1) Lead and implement the establishment and oversight of an Inclusive Research and Patient ... in class diversity and patient voice planning, 3) Design, lead and implement the GCO delivery framework for diversity...review and analysis of site level activities through targeted risk -based site contacts and on-site visits to monitor study… 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)
- …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)
- …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)
- 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)
- … equipment development and maintenance activities -and support facility operations, compliance investigations/change management in any of our enabling ... and/or qualification.Experience providing technical mentorship.Experience in leading and supporting compliance investigations and change management .Familiarity with US… more
