- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP ... Sankyo requirements, and business expectations. Executes the Global DX Computer System Validation methodology to determine the amount of system validation or… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:Oversee and lead the validation program for production equipment and processes used to support manufacturing of aseptic and terminally sterilized ... products. Lead the validation team in the establishment and maintenance of validated...capability. Support manufacturing to satisfy the quality and process validation requirements for existing products. Participate in the development… more
- Arthrex (Pendleton, SC)
- …Treat Their Patients Better (TM) .Main Objective: Responsible for supporting the AMI Validation Manager with all process validation related support for ... education in orthopedics. Arthrex is actively searching for a Senior Quality Assurance Validation Engineer. A minimum of five years of applicable experience and a… more
- Novo Nordisk Inc. (Durham, NC)
- …Relationships Manager . Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC equipment ... help us make what matters. The Position Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed … more
- Schaeffler Group (Troy, MI)
- …oversight, leadership and technical development of the Independent Verification and Validation function within the Thermal Management Systems Business Unit (BU TMM). ... Management Systems product development group with Design Verification and Production Validation (DVP) testing to guarantee quality products for Schaeffler Customers.… more
- CohnReznick LLP (Tysons Corner, VA)
- …strategy development and execution to demonstrate execution progress and measured outcomes (strategy validation )As a Manager in our Data & AI Team, you will ... in everything we do!We currently have an exciting career opportunity for a Business Intelligence Manager to join our team in the Data & AI Advisory team.This is a… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as assigned.-… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Senior Manager , Translational Science Biostatistics will be expected to work independently with minimal ... analysis of human biomarker datasets to inform biomarker identification and validation , clinical development and business strategies. As the study statistician, this… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Manager of Automation Engineering leads Automation Engineers and contractors responsible for instrumentation and controls of manufacturing ... providing input, as necessary.Support the generation and execution of Validation life cycle documentation such as Systems Commissioning, Installation Qualification… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Part D, & Managed Care contracts. This role is responsible for ensuring the validation of formulary eligibility for invoicing of all Commercial and Part D rebates as ... and contract compliance. Relationships This individual contributor role reports to the Sr. Manager of Business Assurance and works closely with various teams in PCOR… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... trials, clinical development, and regulatory submissions. The position will perform validation of the electronically transmitted external data by ensuring all… more
- Global Science & Technology, Inc. (Greenbelt, MD)
- Global Science & Technology, Inc (GST), is seeking a Program Manager to join our team supporting The Center for Satellite Applications and Research (STAR) which is ... to transform satellite observations to environmental measurements. We seek a program manager to lead a multidisciplinary team in atmospheric science and oceanography… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …eligible for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of Automation Engineering ... to identify roles and responsibilities Work closely with Engineering, Automation, Validation , IT, Manufacturing, Quality Assurance and Quality Control, on project… more
- Merck & Co. (Rahway, NJ)
- …DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities ... not limited to: data management tool and system development, validation and maintenance, data integrity review and reconciliation, query...limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a Clinical Data Manager … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...protocol driven activities such as tech transfer and process validation Provides guidance on industry best practices, and quality… more
- Atlas Data Systems (Boston, MA)
- The Project Manager for LIMS is a role within the Technology Program Management Office reporting directly to the Senior Director, DTE Portfolio Manager , with ... matrixed reporting to the Director, Business Engagement & Technology. The Project Manager will have execution delivery responsibilities for the LIMS Deploy Project… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Manager , Regulatory Operations will be responsible for functional activities related ... projects to support the regulatory department as assigned.Provide support in software validation and migration activities relating to new or existing systems in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
