- Merck & Co. (Rahway, NJ)
- … Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality ... and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.Develop… more
- Eisai, Inc (Nutley, NJ)
- …analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. Ability to ... If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for… more
- BioAgilytix (Durham, NC)
- …That means hands-on work designing Azure Data Factory and API integrations, automating data- quality checks, and setting up clear governance so everyone knows who can ... keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a foundational data governance framework, with hands-on… more
- AUROBINDO (Durham, NC)
- …Pharma USA, Inc. is committed to delivering a broad portfolio of quality , affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. ... deplloyment of the electronic laboratory notebook system through training, validation script review, and validation protocols and...hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install… more
- Aequor (Davie, FL)
- …Ensure systems meet GxP, FDA, and ISO standards through robust Computer Systems Validation (CSV) and documentation practices. Cross-Functional Collaborationo ... Work closely with engineering, IT, quality , and manufacturing teams to align automation strategies with business goals.o Support training and change management… more
- Insmed Incorporated (San Diego, CA)
- …and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency throughout the study lifecycle. The AD, EDC ... partners.ResponsibilitiesEDC System Design & Development:Lead the setup, development, and validation of EDC systems, including configuration settings, integration with… more
- Merck & Co. (Lower Gwynedd, PA)
- …vaccines and enable late-stage clinical trials through the generation of timely, high- quality regulated bioanalytical data. As the AdVAnce facility will not be fully ... --Education Minimum Requirement PhD in Biological Sciences, Biomedical Engineering, Data Sciences, Computer Science or related area, or an MS degree with 2+ years,… more
- Merck & Co. (Rahway, NJ)
- …that project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the statistical programming ... lifecycle. Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs… more
- Merck & Co. (North Wales, PA)
- …ensuring that project plans are executed efficiently with timely and high- quality deliverables.For assigned projects the position serves as the statistical ... Primary Activities: Effective analysis and report programming development and validation utilizing global and TA standards and following departmental standard… more
- Merck & Co. (Rahway, NJ)
- …on enterprise data governance frameworks, data ingestion patterns and data quality standardsLeads data contracting and vendor management for strategic data partners ... responsible AI governance, including ethical reviews of GenAI pilots, validation protocols, explainability standards, and human-in-the-loop controlsDevelops and embeds… more
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