- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... functional areas.Drive accountability for processes execution throughout GRACS through change management .-Develop, implement and report process objectives and… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... biopharmaceutics technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (Rahway, NJ)
- …Close partnership with colleagues from Formulation Sciences, Device Development, Quality, Regulatory Affairs, Engineering, and Analytical will be required to ensure ... Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive drug product process development… more
- Merck & Co. (Rahway, NJ)
- …scale capital projects.Experience in leading and supporting quality investigations and change management .Experience with sterile drug product GMP facility ... of topics spanning equipment and facility design, financial and capital management , team building, process sciences, operational excellence, technical writing, and… more
- Merck & Co. (Rahway, NJ)
- …the activities of lab staff, including scheduling, training, and performance management .Ensure adherence to safety protocols and regulatory requirements within ... GMP product testingExperience in leading and supporting quality investigations and change managementExperience with internal / external audit process and authoring… more
- Merck & Co. (Rahway, NJ)
- …at the Rahway site.Integrates EHS programs into daily operations to assure regulatory compliance , continuous improvement and performance objectives are met ... implementing corrective and preventive action plans.Reviews processes, facilities, procedures and management of change documents to assure conformance to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with regulatory requirements and to ... and current regulatory requirements tracking all the complaints, deviations and change control related with the product and creating a trend evaluation scenario… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …amount of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service ... Validation Plans, Protocols (IQ/OQ/PQ), Test Scripts and Summary Reports.Support the change management process for validated systems where necessary.Maintain… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements.Supports Regulatory Affairs in providing quality content and review of documents ... ensuring that outsourced obligations are in compliant and prepared for regulatory submissions and / or inspections Ensures that appropriate systems, processes… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... in a manner that facilitates Health Authority reviews.- Supports company`s GMP Change Management Program. Evaluates CMC changes for portfolio biologics and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Governance Stewardship will work in areas required for the good day-to-day management of data at Daiichi Sankyo including: the stewardship organization, data ... quality, metadata management , lineage capabilities and the data governance processes surrounding these capabilities, and the data governance program in general. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …skills in technology systems, content creation, word processing software and data management software, and business emailing software as well as intermediate skills ... Operations, candidate is responsible to support the implementation of culture change initiatives, Global QA Transformation activities and project level oversight… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge in maintenance/metrology management , broad understanding of facilities management , cGMP compliance , EHS and regulatory standards ... preventative maintenance (PM) & predictive maintenance (PDM) practices to ensure compliance (cGMP) with company policies and appropriate regulatory … more
- Eisai, Inc (Nutley, NJ)
- …or user acceptance testing, and integrations with other clinical applications through change management . Maintains the eTMF system including secure storage, ... relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws...and serve as a subject matter expert in TMF Management . This position may be office-based (hybrid) in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls and complaintsReview and approve manufacturing proceduresSupport regulatory inspections and audits by ensuring inspection readiness within ... while ensuring high quality and complaint product supply.Key ResponsibilitiesSupport compliance activities for site Quality Operations in accordance with Legend… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strong communication skillscGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards ... limited to: support to manufacturing equipment projects, costimprovementinitiatives, asset management , reliability, and business operations.Support facility project initiatives as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …supporting corrections and CAPAs.Lead continuous improvement associated with investigation management .Support regulatory inspections and audits by ensuring ... Operations, Operations Technical Support, Maintenance, Supply Chain and Planning.Approve the change in scope or level of an investigation.Perform timely escalations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines, specification & critical limitsServes ... product meeting or exceeding the standard of various health authorities. Stakeholder management is required to drive and implement process validation program efforts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in a fast paced and dynamic, growing environment.Strong understanding of regulatory and compliance requirements.Excellent oral and written communication ... system/equipment changes from identification through implementation/release, including the associated Change Controls.Develop/own asset lifecycle documentation from URS development to… more
