Global Quality Assurance Executive Leader

BioCryst Pharmaceuticals, Inc.; Durham (NC); On-site; USD 350,000 - 550,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. in Durham, North Carolina, seeks an SVP, Global Quality Assurance to lead the global Quality organization and GxP strategy across development, clinical, commercial, distribution, and post-market operations.

You will shape a fit-for-purpose QMS, drive inspection readiness, risk-based decision-making, and leverage digital tools, analytics, automation, and AI to modernize quality systems while ensuring compliance.

Qualifications

• Master’s degree in a scientific or related discipline is required; advanced degrees preferred.
• 15+ years of progressive Quality leadership in pharma/biotech, with global GxP exposure.
• Proven track record in health authority inspection strategy and remediation.

Responsibilities

• Set enterprise GxP Quality vision and strategy across development, clinical, commercial, distribution, and post-market.
• Lead global oversight of GLP, GCP, GMP/GDP, GVP, and QMS activities.
• Design and continuously improve a fit-for-purpose global QMS; ensure scalability and risk-based operations.
• Advance digital strategy, analytics, automation, and AI-enabled capabilities within QMS.
• Establish executive-level Quality metrics and governance; monitor CAPA, cycle time, and data integrity.
• Oversee quality/compliance for internal ops and outsourced partners; manage audits and follow-ups.
• Lead inspection readiness and health authority strategies; coordinate across global regulators.
• Build and develop a high-performing global Quality organization; budget stewardship; succession planning.

Skills

Global Quality leadership

GxP knowledge

Regulatory collaboration

Digital QA modernization

Executive communication

Education

Master’s degree in science or related field

Job description

BioCryst Pharmaceuticals, Inc. in Durham, North Carolina, seeks an SVP, Global Quality Assurance to lead the global Quality organization and GxP strategy across development, clinical, commercial, distribution, and post-market operations.

You will shape a fit-for-purpose QMS, drive inspection readiness, risk-based decision-making, and leverage digital tools, analytics, automation, and AI to modernize quality systems while ensuring compliance.