- Tris Pharma (Monmouth Junction, NJ)
- …recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and ... Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality … more
- Insmed Incorporated (San Diego, CA)
- …with GTx Technical Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. ... the overall effectiveness of the Quality departmentAssist in other quality assurance related activities as agreed with management .Knowledge & Experience7+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …by the GQLs, EPQLs, and BPQLs, to internal and external stakeholders of R&D Quality .Support the oversight and management of CAPAs by tracking and following up ... of relevant quality reports and outputs (JOC, QRB, QQRs, EMR).CAPA Management Support the oversight and management of QE-related CAPAs by tracking… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The ITSM Process Manager for Change Management is responsible and accountable for managing and ... maintaining the IT Change Management process. You should be familiar with normal, standard,... process. Through careful coordination with stakeholders and consistent quality assurance, minimize the risk of changes,… more
- Merck & Co. (Durham, NC)
- …skill sets in planning / scheduling, and time management .Experience with Quality Risk Management .Experience with Deviation Management .Experience with ... Floor QA proceed in compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …project management tools such as Workfront, the Content Project Manager monitors task progress, mitigates risks, and maintains efficient workflows. This position ... ensuring that all stakeholders are aligned and informed. Ultimately, the Content Project Manager plays a critical role in delivering high- quality digital content… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and external ... written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processing of requests and delivery of periodic review reconciliation reports Project Management : Manage all quality deliverables for the timely processing of ... members for each study. Establish appropriate work procedures/guidance, logs, templates, quality procedures, risk impact assessment mitigation procedures, to… more
- Merck & Co. (Durham, NC)
- …drug substance or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in ... proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Provide QA shop floor...cleaning validation documentation as needed. May act as a Quality Risk Assessment Lead. - - Education… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …audienceAt least 8 years' experience in the biotech/pharmaceutical industry in validation, quality management , process controls, and continuous improvement in an ... process validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a fast-paced environment, continuous improvement, project management , change management , and risk management .Responsibilities:Leadership, Direction, and ... around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical...safety and pharmacovigilance, CROs, and partners to ensure high quality coding deliverables are on time to support drug… more
- Merck & Co. (Rahway, NJ)
- …Support compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead ... Experience in one or more functional areas such as quality assurance, laboratory, manufacturing, production, equipment/facilities management , regulatory.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … discipline and its application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results in creating ... project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk , cost, time are managed within the overall approved… more
- Merck & Co. (Durham, NC)
- …learning events, or business support initiatives, as guided or approved by Quality management .Train employees on new or revised processes or procedures.Review ... of technical and operational problems through collaboration with peers.Applies appropriate risk management while adhering to cGMP requirements.Makes decisions… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …The Quality Engineer will participate in Internal Audits as directed by the Quality Manager . In addition, the Quality Engineer will lead continuous ... risk in process validations, and continues with overseeing risk using statistical quality control during manufacturing....understood by engineering and incorporated into design and control functions. Risk Management - assures risk … more
- Merck & Co. (Durham, NC)
- …drug substance or drug product. GMP experience with qualification of equipment. Experience with Quality Risk Management . Project Management experience in ... the project proceed in compliance with cGMP, regulations, and our Company's Quality Management System. Supporting areas such as Design, Commissioning,… more
- Novo Nordisk Inc. (Virginia, WA)
- …departments influencing diabetes and obesity care (eg, diabetes centres of excellence, quality , care management , population health, and other key departments ... with superior ability to lead through change. Relationships Internally, the Educator Manager (EM) reports to a Region Business Director (RBD) in the Commercial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and Risk Evaluation and Mitigation Strategy (REMS) including the management and oversight of systems supporting these processes. It involves coordinating and ... Implements and oversees automation processes to improve data reviews and data quality for ensuring government obligations Tracks all policy and contract template… more
- Novo Nordisk Inc. (Los Angeles, CA)
- …risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …colleagues to implement continuous improvement opportunities, review issues log, develop risk mitigations strategies and ensure all systems are operating well as ... and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment...delivery and follow through execution.- Assist with the daily management of the customer support ticketing system for the… more
