Genovice INC
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Agency • Healthtech • Professional Services • Biotech
Supports end-to-end electronic Quality Management System implementations for pharmaceutical and biotechnology clients. Responsibilities include project coordination, system configuration, data migration, validation documentation, requirements gathering, testing, UAT, stakeholder communication, go-live support, and training. The role requires QMS platform experience, knowledge of GxP and 21 CFR Part 11, and the ability to manage technical and business activities across implementation projects.
Agency • Healthtech • Professional Services • Biotech
Leads quality-system development and computerized system validation governance for a regulated technology company. Responsibilities include building the QMS, authoring SOPs, overseeing document and change controls, CAPA, deviations, training, supplier quality, audits, validation reviews, data-integrity controls, inspection readiness, and regulated product-release approvals. The role provides independent Quality oversight rather than executing routine testing and requires approximately 20 hours per week.
