- CGI Technologies and Solutions, Inc. (Cambridge, MA)
- ** Veeva QMS Subject Matter Expert (SME)** **Category:** Testing/Quality Assurance **Main location:** United States, Massachusetts, Cambridge **Position ... . **Position Description:** We are seeking a highly experienced Veeva QMS Subject Matter Expert (SME) to… more
- Lilly (Durham, NC)
- …deviations, Change Controls and CAPA. + Authors, periodic reviews, and acts as Subject Matter Expert for RTP One- QMS Veeva System. + Support and initiate ... with actions, timelines on a routine basis + Act as Power User / Site Instructor for the new One QMS Veeva system and for programs within the system such as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and ComplianceWire reports and dashboards. + Establish a network of Vault reporting Subject Matter Experts (SMEs) representing and supporting various sites and ... support of all of Gilead's enterprise-wide Quality Management Systems. These include Veeva Vault QMS and QualityDocs and the ComplianceWire Learning Management… more
- Amgen (Washington, DC)
- …research subjects and that all data has integrity. + Serve as a GCP Subject Matter Expert, providing independent and objective quality advice supporting business ... program. The R&D Process Quality team supports the Quality Management System ( QMS ) across all Amgen research areas, including discovery through the clinical… more
- Bristol Myers Squibb (Devens, MA)
- …of collaboration and accountability. SOP Development and Revision: + Collaborate with subject matter experts and cross-functional teams to develop new SOPs ... in using quality management and analytical software and tools. Veeva Quality Suite and Tableau experience a plus. **Key...with suppliers to enhance performance and meet business objectives. QMS Health & Maturity: + Establish and execute on… more
- Nestle (Brisbane, CA)
- …to ensure effective change control, testing, validation, and communication. + Act as a subject matter expert for the IT GxP Compliance Program. + Partner with ... management software in the biotechnology or pharmaceutical industry. + Experience with Veeva RIMS, QMS , QDocs, SAS, PleaseReview, LabVantage LIMS, ServiceNow,… more
- Lilly (Durham, NC)
- …for product and process performance + Authors, periodic reviews, and acts as Subject Matter Expert for RTP site Product Complaint Management procedures. + ... and data steward for the Complaint Management TrackWise / Veeva system and performs complaint investigations for RTP manufacturing,...readiness plan with focus on supporting transfer to new QMS system and provide oversight of the establishment of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …personnel in preparation for regulatory agency inspections **.** + Leads and/or advises Subject Matter Experts on responses to regulatory agency inquiries and ... and potential risks and integrates into the Quality Management Review. + Drives for Veeva QMS record development on all inspection findings and action plans,… more
- Merck (Lower Gwynedd, PA)
- …Community of Practice, develop and maintain global training materials, and be a subject matter expert on information systems supporting change control. **Primary ... website. + Network with functional groups performing change control to provide subject matter expertise, provide direction, and implement best practices and… more
- Kelly Services (Cambridge, MA)
- …quality assurance matters as well. Job Duties Include: + Serve as a Subject Matter Expert for Quality Assurance in commissioning and decommissioning activities ... events including Change Controls, CAPAs, and Deviations. + Proficiency with Veeva QMS , Blue Mountain RAM and Kneat (or similar paperless validation systems)… more
- Amgen (Washington, DC)
- …who participate in Amgen sponsored trials. **Responsibilities** + Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in ... of **Quality Management Systems** and experience managing quality in electronic QMS such as Veeva or Track wise. + Thorough understanding of **Clinical R&D… more