Global Quality SVP - AI-Driven QMS & Compliance

BioCryst Pharmaceuticals; Durham (NC); On-site; USD 250,000 - 360,000; Full time

Job summary

BioCryst Pharmaceuticals seeks a visionary SVP, Global Quality Assurance to lead the enterprise-wide GxP Quality strategy. You will shape a modern, compliant QMS, drive AI-enabled improvements, and partner with executive leadership to enable scalable growth across development, clinical, and commercial operations.

You will lead a global team, oversee inspections, and collaborate with regulatory agencies to ensure continuous readiness and risk-based decision-making in a fast-paced, remote-enabled

Qualifications

• Master's degree in a scientific or related discipline is required.
• 15+ years of progressive Quality leadership in pharma/biotech; global GxP leadership.
• Experience with FDA/EMA/PMDA inspections and remediation.
• Deep knowledge of cGMP, GLP, GCP, GVP, GDP and QMS across product lifecycle.
• Strong communication and executive leadership with cross-functional collaboration.

Responsibilities

• Sets global GxP Quality vision, strategy and culture to enable compliant, scalable operations.
• Leads cross-functional quality oversight across GLP, GCP, GMP/GDP, GVP and QMS activities.
• Designs and improves a fit-for-purpose global QMS aligned to the business model.
• Drives digital modernization of the QMS using analytics and AI-enabled capabilities.
• Establishes executive-level quality metrics and governance for QMS performance and AI impact.
• Oversees quality and compliance for internal ops and outsourced partners; manages inspections.
• Leads regulatory inspection strategy and readiness with health authorities.
• Partners with clinical, regulatory, supply chain, IT and other functions to enable compliant growth.
• Builds and mentors a high-performing global quality organization; manages budget.

Skills

Executive leadership

Stakeholder communication

Risk-based decisions

Digital strategy

Regulatory knowledge

GxP compliance

Education

Master's degree in science or related field

Advanced degree preferred

Tools

QMS software

Analytics tools

Automation platforms

Job description

BioCryst Pharmaceuticals seeks a visionary SVP, Global Quality Assurance to lead the enterprise-wide GxP Quality strategy. You will shape a modern, compliant QMS, drive AI-enabled improvements, and partner with executive leadership to enable scalable growth across development, clinical, and commercial operations.

You will lead a global team, oversee inspections, and collaborate with regulatory agencies to ensure continuous readiness and risk-based decision-making in a fast-paced, remote-enabled