- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance , Medical ... and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system validation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management , Quality Assurance , Medical ... Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management . Develop a strong, positive strategic business… more
- Eisai, Inc (Nutley, NJ)
- …IT business stakeholders on business continuity, governance, and audits.Manage global IT Risk Management Procedure and third-party risk assessments.Establish ... teams in the execution of Risk and Compliance initiatives and support professional growth. Risk Management : Develop and manage global risk management … more
- Merck & Co. (Upper Gwynedd, PA)
- … management and follow up of regulatory inspections.Primary Responsibilities:Operational Quality Management Develop Risk Assessment and Categorization ... include ongoing partnership with the Research & Development Division Quality Assurance (QA) and acting as the...GCP Quality and Compliance Council regarding the Quality Management System (QMS), Risk … more
- Tris Pharma (Monmouth Junction, NJ)
- …recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in the design (and ... Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS). Summary:The Manager, ...Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product … more
- Merck & Co. (Rahway, NJ)
- …will play a pivotal leadership role within the organization, overseeing the quality assurance and regulatory CMC for complex medical devices, including ... clear performance goals and metrics for the team to drive excellence.Device Quality OversightOversee the quality assurance of complex devices,… more
- Merck & Co. (Durham, NC)
- …including latest trends in validation and best practices. Represent Digital & Data Quality management upon request in local site or system specific meetings ... Job DescriptionResponsibilities: Responsible for the quality aspects of good manufacturing practices (GMP) computerized...initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work. Provide… more
- Aequor (Thousand Oaks, CA)
- …functional, quality , timeline and cost issues appropriately. Utilize project management processes, software and methodologies to ensure projects are delivered on ... for leading cross-functional teams in new raw material onboardings, life-cycle management projects, and continuous improvement initiatives. This will require working… more
- Merck & Co. (Rahway, NJ)
- …confidence in a changing world.-We provide value-added independent and risk -based audit, assurance and advisory services.Position Responsibilities:The successful ... and testing information technology general controls (ITGCs) to provide reasonable assurance that adequate application and infrastructure internal controls are both… more
- Merck & Co. (Rahway, NJ)
- …a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.Corporate Audit and Assurance Services ... a deeper knowledge of internal controls, business compliance, and risk management . Individuals will be based in...walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research relevant duties under the RDPV QA function to ensure that Quality assurance oversight are being addressed and managed appropriately. Ability to ... requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of corrective and preventive actions, as necessary.Supports internal/external audits.Supports Quality risk assessment teams.Review/approve documents as a ... candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Merck & Co. (Durham, NC)
- …improvement, learning events, or business support initiatives, as guided or approved by Quality management . Train employees on new or revised processes or ... of technical and operational problems through collaboration with peers.- Applies appropriate risk management while adhering to cGMP requirements. Makes decisions… more
- Merck & Co. (North Wales, PA)
- …b) Data Mastering, Data Governance including but not limited to Data Marketplace, Data Quality , Data Risk Management c) Value Realization with use of ... the decision. Operate with Integrity and ensure adherence with organization policies, quality assurance and data protection processes.Conduct innovation proof of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities, timelines and resource requirements for CSV projects. Work within a risk -based framework (Computer Software Assurance (CSA)) that is compliant with ... issues, Good Automated Manufacturing Practices (GAMP5) and Good Practices Guides, Risk -Based Approach/Computer Software Assurance (RBA/CSA) to assure related… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …critically review investigations, interpret results and generate technical conclusion consistent with Quality risk management principles.Must be able to ... required. Advanced degree preferred.A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma… more
- Novo Nordisk Inc. (Boulder, CO)
- …our patients Work effectively across all departments, such as Quality Assurance / Control, Chemical Development, Program Management , Regulatory, Quality ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Aequor (Louisville, KY)
- …4&plus years' experience in GMP / GDP compliance Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice. ... Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (eg Trackwise, EDMQ, etc) Preferred… more
- BioAgilytix (Durham, NC)
- …budget.Workstream Coordination: Manage all internal BioAgilytix teams (lab operations, IT, quality assurance ) and external resources to ensure efficient project ... project plans, timelines, and budgets using Smartsheet to ensure smooth project execution. Risk & Issue Management : Identify and resolve project risks, issues,… more
- BioAgilytix (Boston, MA)
- …and projects related to system implementation (eg, integrations, data integrity and risk management ).Perform periodic application review and management of ... and regulatory auditsContribute to computer system validation and computer software assurance projects, including change control as required by GxP Establish open… more
