Global Quality SVP: AI-Driven QMS & Compliance

BioCryst Pharmaceuticals, Inc.; North Carolina; Vor Ort; USD 250.000 - 350.000; Vollzeit

Zusammenfassung

BioCryst Pharmaceuticals, Inc. seeks a strategic and experienced SVP, Global Quality Assurance to lead BioCryst’s global Quality organization and GxP Quality strategy.

You will drive inspection readiness, risk-based decision making, and AI-enabled modernization of the QMS, partnering with senior leaders to enable compliant growth and lifecycle execution. The role requires extensive leadership across GLP, GCP, GMP/GDP, and QMS, with a track record of managing health authority inspections and

Qualifikationen

• Master’s degree required; advanced degree preferred.
• 15+ years of progressive Quality leadership in pharma/biotech.
• Global GxP leadership across multiple product lifecycle stages.
• Experience with health authority inspections (FDA/EMA/PMDA) and QMS.

Aufgaben

• Set enterprise GxP Quality vision and strategy across development, clinical, commercial, distribution, and post‑market operations.
• Lead global Quality oversight for GLP, GCP, GMP/GDP, GVP and QMS activities.
• Design and continuously improve a fit‑for‑purpose global QMS aligned to BioCryst’s business.
• Advance digital strategy, analytics, automation, and AI to modernize the QMS.

Kenntnisse

Executive leadership

Strategic thinking

Data analytics

AI capabilities

Regulatory knowledge

Ausbildung

Master's degree in science/related field

Jobbeschreibung

BioCryst Pharmaceuticals, Inc. seeks a strategic and experienced SVP, Global Quality Assurance to lead BioCryst’s global Quality organization and GxP Quality strategy.

You will drive inspection readiness, risk-based decision making, and AI-enabled modernization of the QMS, partnering with senior leaders to enable compliant growth and lifecycle execution. The role requires extensive leadership across GLP, GCP, GMP/GDP, and QMS, with a track record of managing health authority inspections and