Genisage jobs and careers

About Genisage

Genisage is a specialized consulting firm helping life sciences companies navigate the complex intersection of regulatory compliance, quality systems, and modern data infrastructure. Our mission is to empower innovation through compliance—whether you’re launching a new therapeutic, scaling a quality system, or preparing data for AI-driven insights. We work with pharmaceutical, biotech, medical device, and diagnostics companies to build inspection-ready systems, achieve regulatory approvals, and manage data in a way that is structured, traceable, and aligned with global regulatory expectations. ⸻ Our Services Include: Quality & Regulatory Consulting • Quality Management System (QMS) development & implementation • Medical Devices, Combination Products, Pharma • ISO 13485, 21 CFR 820, 211, and Part 4 compliance • Internal audits, CAPA, risk management, and audit readiness • Regulatory strategy & submissions • Audits: Supplier, Internal, Surveillance, ISO readiness, MDSAP Readiness, EU MDR Data & Technology Consulting • Software Lifecycle Development • AI/ML validation & audit readiness • Data readiness: curation, governance & labeling • Regulatory compliant data infrastructure (SOC2, GDPR) • GxP-aligned cloud architecture (AWS, Azure) • Information and Cybersecurity • IT vendor qualification for regulated environments Whether you’re preparing for inspection, validating software, or scaling AI solutions, Genisage delivers innovative, compliant solutions built for regulated success. 🌐 www.genisage.com