- Novo Nordisk Inc. (Durham, NC)
- …a strong high performing cross-functional team Develop relationships with Novo Nordisk project organization & validation project contributors (local & ... project environment preferred Experienced in the development, implementation, validation &/or maintenance of equipment & facilities in the pharmaceutical/medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with project stakeholders.- Provide oversight to assure that all validation work performed for Daiichi Sankyo by various contractors meets Global DX ... rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems supporting GxP… more
- Novo Nordisk Inc. (Durham, NC)
- …QM module a plus Working knowledge of GMPs required Ability to act as project manager driving & implementing equipment projects required Demonstrated ability to ... Relationships Manager . Essential Functions Ensure accuracy & compliance of validation & equipment records Responsible for validation of QC equipment… 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 systems. Coordinate technology transfer activities in support of… more
- BioAgilytix (Boston, MA)
- …project support through all phases of our client services. We are currently seeking a Project Manager I or II to join our Project Services' teamin Boston. ... working in a GxP environment preferredFamiliarity with NetSuiteEducation/ Experience ( Project Manager I):Bachelor's degree in life science, business… 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 ... with direct/indirect referral: 0 Essential Functions Planning and coordination of the project deliverables and project team on a day-to-day basis, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …lead a team of API Optimization Specialists, Manufacturing Area Specialists, and Project Managers in the execution of the manufacturing suite robustness and capacity ... capacity. Responsibilities include team development, delivery of the associated project portfolio, status reporting, budgeting, training and planning. The role… more
- Merck & Co. (Rahway, NJ)
- …data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials ... Job DescriptionThe Trial Manager creates and ensures the successful execution of...project -level consistency of database design, data collection, and validation .Facilitates assessment and processing of standards and change requests.Approves… more
- Novo Nordisk Inc. (Durham, NC)
- …& regulatory requirements in accordance with the Novo Nordisk Way. Relationships Senior Manager . Essential Functions Manage and guide team to maintain plans to meet ... Collaborate with Site Leadership on workload solutions & advocate for IT project and resource prioritization Frequent planning to ensure resources are in place… more
- Aequor (Austin, TX)
- …and procedures, providing support and corrective actions where required Assists overall Project Manager with all matters related to strategic sourcing and ... as liaison between Project Delivery teams and suppliers Develop and maintain Project Sourcing Plan with Project Manager as a \"living document\"… 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
- Catalent (St. Petersburg, FL)
- …on trend analysis to eliminate future problems. Participates in Product Development/ Validation /Engineering project meetings to provide Quality Assurance input ... QA Product Manager Position SummaryThe QA Product Manager ...projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all… 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
- Eisai, Inc (Nutley, NJ)
- …and IT Operations. Partner with ITQA, Business Owner and IT Project Manager for defining a master validation strategy where applicable. Partner with R&D ... Steering Committees in collaboration with Business Owner and Project Manager . Represent business needs to the...application / system changes in accordance with computer system validation , 21 CFR Part 11 and GxP policies. Send… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... CRF review, SAP development, analysis files development, statistical analysis accuracy validation , results interpretation and CSR input and review. Acts as main… more
- Novo Nordisk Inc. (Durham, NC)
- …of raw materials & provides quality oversight, review & approval of validation activities associated with minor changes to existing systems. Performs archiving ... & QA presence & process confirmation on shop floor. Relationships Manager , Quality Assurance. Essential Functions Ensures site compliance with Regulations, ISO… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …formats. Job Responsibilities: Analyze production and processing problems and initiate project definitions to resolve themDesign or specify equipment to meet ... waste-related issuesDirect and coordinate activities of various vendors for each project to eliminate any potential conflict and assures that vendors comply… more
- Doosan Bobcat (Bismarck, ND)
- …quickly learn and execute projects following the company's product development and validation processes, project timeliness, and manager guidanceProven ... skills and experience using various engineering tools related to design and validation of new and existing products: Creo and/or other computer engineering tools,… more
- Aequor (Seattle, WA)
- …Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation , etc.). Must complete tasks independently, notify manager ... with cross functional departments to finalize time-sensitive deliverables. Possess project management skills. Experience interacting with FDA or other regulatory… more
- Bering Straits Native Corporation (Jamestown, ND)
- …town, North Dakota.The Lab is under construction. The Project Engineer Lab Manager will participate in the certification and validation through the Engineer ... Bering Straits Native Corporation is currently seeking a qualified project Engineer Data Manager for the United...will be familiar with all testing requirements for this project by the time validation of the… more
