- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with business functions. Provide expert guidance to enable successful inspections .Lead/Support local inspections by providing adequate systems ... issues in a timely manner for earliest resolution, Regulatory Inspections :Facilitates regulatory inspection preparation, management, and follow-up, ensuring… more
- Eisai, Inc (Nutley, NJ)
- …of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue management and oversight of the Quality management system. ... high visibility position with great impact potential. Essential Functions Direct and drive design, delivery, and execution of the global Clinical Quality Assurance… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensuring compliance.Support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections .Serves as ... improvement.The Compliance Auditor will conduct internal audits, support regulatory inspections , and lead investigations to ensure process integrity and GMP… more
- Merck & Co. (Lower Gwynedd, PA)
- …will oversee the quality and compliance of vaccines clinical testing and drive the implementation and optimization of compliant processes and procedures. -This will ... trending. The candidate will also participate in data reviews or process inspections to ensure generation of quality data, maintain metrics associated with quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections .Lead facility ... operating review meetings and sponsor various department projects to drive continuous improvements and efficiencies within cell therapy Technical Operations.Support… more
- Merck & Co. (Lower Gwynedd, PA)
- …writing (eg regulatory responses, SOPs, etc.), management of QA and regulatory inspections , review of data and lab processes, driving the evolution of systems ... regulatory responses. --Conducts review of all laboratory data to drive high quality documentation, data integrity, staff adherence to...and other operational aspects of the lab not managed by the assay or robotics teams. --Applies business and… more
- Eisai, Inc (Nutley, NJ)
- …North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is ... clinical documents, and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive… more
- Merck & Co. (Rahway, NJ)
- …team members to support global commercialization and technology transfer activities and drive product robustness for sustained launch in alignment with the company's ... with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development team and… more
- Merck & Co. (Rahway, NJ)
- …staff to support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's ... manufacturing are considered as part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of ... to address, escalate issues requiring attention or resolution, and proactively drive operational excellence and continuous improvement. Manage DSI's Strategic PV… more
- Merck & Co. (North Wales, PA)
- …QMS framework. Key responsibilities include participation in Health Authority Inspections , oversight of the Issue Management Process-including execution and ... of Practice for individuals outside OPS who implement QMS procedures governed by this role. Strategic duties involve providing proactive assessments of compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of ... to the timeline, budget and quality measures set forth by the Study teams. This leader will also ensure...close site relationships (such as our Network sites) and drive the CRO to quality, cost, and shortened timelines… more
- Merck & Co. (Rahway, NJ)
- …level with key functional areas.Oversee design verification activities performed by external partners.Proactively anticipate and resolve project obstacles and ... environmental conditions, ie, temperature, humidity.Eagerness to identify lab capability gaps, drive procurement of new equipment, and quickly upskill (also train… more
- Merck & Co. (Lower Gwynedd, PA)
- …will oversee the quality and compliance of vaccines clinical testing and drive the implementation and optimization of compliant processes and procedures. -The ... candidate will participate in data reviews or process inspections to ensure generation of quality data, maintain metrics...Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a… more
- Merck & Co. (Rahway, NJ)
- …and assist in developing/implementing CAPAs.Provide documentation/technical input during inspections and audits (Regulatory and Internal).Core Competencies Required ... along with demonstrated ability in asking the right questions to drive critical conversationsPreferred Experience and Skills:Working knowledge of pharmaceutical drug… more
- Novo Nordisk Inc. (Durham, NC)
- …work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments ... of lives. Because it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is...disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.… more
- Aequor (South San Francisco, CA)
- …content owners to support efficient review, approval, publication, and archival processes. Drive adoption of taxonomy best practices across tools and teams. Improve ... content findability by enabling structured navigation, tagging, synonym management, and filtering systems. Partner with UX and engineering teams to enhance internal… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to ensure the success and overall sustainability of global commercial program by adhering to industry best practices and sound cell therapy technical principles ... CAR-T product.Work collaboratively with internal and external partners to drive global process platform improvements and cost reduction initiativesDrive strategy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the Site Readiness of MES for FDA and/or Other Regulatory Audits / Inspections .This individual is responsible for the training of Manufacturing Excellence on MES ... the evaluation of potential process changes for effectiveness, value, risk, and priority. Drive the implementation of MES enhancements that would provide reduction in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Readiness of MES for FDA and/or Other Regulatory Audits / Inspections .Establish key stakeholder relationships with internal and external stakeholders. Ability to ... partnerships and effectively integrate with cross functional collaborators to drive projects/programs forward in a matrixed environment.Strong analytical, problem… more
