Global Quality Assurance & Compliance Leader (GxP)

Regulatory Jobs; Durham (NC); On-site; USD 250,000 - 360,000; Full time

Job summary

BioCryst seeks an SVP, Global Quality Assurance to lead the global Quality organization and shape the QMS strategy across development, clinical, commercial, distribution, and post‑market operations.

The role drives inspection readiness, risk‑based decision making, continuous improvement, and digital modernization with AI capabilities, partnering with senior leaders to enable compliant growth and lifecycle execution.

Qualifications

• Master’s degree in a scientific or related discipline.
• 15+ years of progressive quality leadership in pharma/biotech.
• Experience in global GxP requirements (cGMP/GLP/GCP/GVP/GDP).
• Proven track record with health authority inspections (FDA/EMA/PMDA).
• Experience integrating digital tools, data analytics, automation and AI in QMS.

Responsibilities

• Set enterprise GxP Quality vision and strategy across development, clinical, commercial, distribution, and post‑market operations.
• Lead global Quality oversight across GLP, GCP, GMP/GDP, GVP, and QMS activities.
• Design and improve a fit‑for‑purpose global QMS aligned to the business model.
• Advance digital strategy, analytics, automation, and AI to modernize the QMS.
• Establish executive‑level Quality metrics and governance routines.
• Oversee Quality and compliance for internal operations and outsourced partners.
• Lead inspection readiness and health authority inspection strategy and remediation.
• Identify and mitigate material Quality risks with executive accountability.
• Collaborate with cross‑functional teams to enable compliant growth.
• Build and lead a high‑performing global Quality organization.

Skills

GxP leadership

Quality strategy

Regulatory knowledge

Executive communication

Education

Master's degree in science

Tools

QMS platforms

Job description

BioCryst seeks an SVP, Global Quality Assurance to lead the global Quality organization and shape the QMS strategy across development, clinical, commercial, distribution, and post‑market operations.

The role drives inspection readiness, risk‑based decision making, continuous improvement, and digital modernization with AI capabilities, partnering with senior leaders to enable compliant growth and lifecycle execution.