Vice President, Regulatory & Quality
Core
Develop and lead global regulatory strategy and quality oversight for diagnostic products to ensure compliance and support commercialization.
Role type
VP, Regulatory & Quality (Senior Leadership)
Builds
Diagnostic products (immune medicine, NGS technology)
Domain
Life Sciences / Diagnostics / Immune Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global regulatory strategy, Quality Management System (QMS) leadership, FDA/global agency relations, ISO/CLIA/CAP/GxP compliance, product lifecycle management, strategic planning, cross-functional leadership, deviation management, inspection readiness
Preferred skills
Advanced degree (MS/PhD), NGS technology experience, hematology/oncology/immunology therapeutic areas, pharma partner collaboration
Technologies
NGS technology
Responsibilities
Lead and mentor Regulatory Affairs and Quality Assurance teams; oversee preparation and filing of regulatory documents with FDA and international agencies; develop and maintain the Quality Management System (QMS); provide counsel on regulatory requirements; manage deviation events and compliance risks; collaborate with executives and external partners on commercialization plans.
Seniority
VP, Executive Leadership
