- BeiGene (San Mateo, CA)
- …Systems. + Ensure Digital Quality applications are inspection-ready and serve as a Subject Matter Expert (SME) during Health Authority inspections. + Lead and ... **General Description:** The Senior Director, Digital Quality Management Systems ( QMS ) Strategy and Operations, leads the digitalization of the QMS and supports … more
- Lilly (Concord, NC)
- …change controls, and CAPA. + Author and review documentation as a Subject Matter Expert for the CONCORD site's One QMS . Qualifications: + Bachelor's or ... + Manage the transition of the Quality Management System ( QMS ) from the TrackWise platform to Veeva for the CONCORD site. + Collaborate with the global… 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
- University of Pennsylvania (Philadelphia, PA)
- …specialists with the CVPF training program. + Review any procedures related to this subject matter area. + Maintain employee training binders. + Send and ... GMP/GLP environment is required. + Experience with a digital QMS such as Veeva , Title 21, or...have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always… 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
- Vera Therapeutics (Brisbane, CA)
- …execution for the Clinical QA function. * Provides Clinical QA (GCP) leadership and Subject Matter Expertise (SME) to clinical study teams. * Ensures the ... with planning and conducting GCP focused audits preferred. * Proficient in Veeva QualityDocs and Veeva QMS . * Demonstrates proven track record of leadership,… more
- Amgen (Washington, DC)
- …health authorities, including root cause and CAPA plans. + Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of ... of **Quality Management Systems** and experience managing quality in electronic QMS such as Veeva or Track wise. + Thorough understanding of **Clinical R&D… more