SVP, Global Quality Assurance

•       Sets the enterprise GxP Quality vision, strategy, and culture in partnership with the executive leadership team, ensuring Quality is a competitive advantage for BioCryst.

•       Leads global Quality oversight across GLP, GCP, GMP/GDP, GVP, and QMS activities spanning development, clinical, commercial, distribution, and post-market operations.

•       Designs, governs, and continuously improves a fit-for-purpose global QMS that is compliant, scalable, risk-based, and aligned to BioCryst’s business model.

•       Advances digital strategy, analytics, automation, and AI-enabled capabilities to modernize the QMS, strengthen compliance intelligence, improve decision-making, and reduce non-value-added work.

•       Establishes executive-level Quality metrics and governance routines to measure QMS performance and AI impact, including cycle time, right-first-time execution, CAPA effectiveness, inspection readiness, user adoption, data integrity, and productivity gains.

•       Oversees Quality and compliance for internal operations and outsourced partners, including manufacturing, testing, release, distribution, audits, inspection commitments, and follow-up actions.

•       Leads inspection readiness and health authority inspection strategy, execution, remediation, and sustained compliance across relevant global regulatory agencies.

•       Identifies, escalates, and mitigates material Quality and GxP compliance risks through clear accountability, risk-based decisions, and executive-level communication.

•       Partners with Pharmaceutical Sciences, CMC, Clinical, Regulatory, Supply Chain, Medical Affairs, IT, Pharmacovigilance, Finance, and Business Development to enable compliant growth, partnerships, and lifecycle execution.

•       Builds, develops, and leads a high-performing global Quality organization, including workforce planning, capability development, succession planning, and budget stewardship.

•       Assumes additional enterprise leadership responsibilities as business needs evolve.

LEADERSHIP PROFILE:

·         Enterprise-minded Quality leader who balances patient safety, regulatory compliance, business agility, and commercial reliability.

·         Culture builder who raises Quality ownership across the organization while simplifying systems and reinforcing accountability.

·         Transformation-oriented executive who uses data, technology, automation, and AI-enabled capabilities to improve performance and scale.

·         Pragmatic, risk-based decision-maker with credibility across regulators, partners, senior leaders, and Board-level stakeholders.

EXPERIENCE & QUALIFICATIONS:

•       Master’s degree in a scientific or related discipline required; advanced degree preferred.

•       15+ years of progressive Quality leadership experience in the pharmaceutical or biotechnology industry, including at least seven years in senior global GxP leadership roles.

•       Enterprise-level experience across early development, clinical, commercial, distribution, and post-market Quality operations, with international experience preferred.

•       Deep knowledge of global GxP requirements, including cGMP, GLP, GCP, GVP, GDP, and QMS expectations across the product lifecycle.

•       Proven track record leading health authority inspection strategy, execution, remediation, and sustained inspection readiness with FDA, EMA, PMDA, and other global agencies.

•       Strong technical and regulatory understanding of biologics and small molecules, including drug substance, drug product, finished product, external manufacturing, testing, release, and distribution operations.

•       Demonstrated ability to design, scale, and continuously improve risk-based Quality systems in complex, outsourced, and global operating models.

•       Experience applying digital tools, data analytics, automation, and AI-enabled capabilities to improve QMS performance, compliance intelligence, and operational productivity.

•       Executive presence with strong communication, negotiation, influencing, and presentation skills, including the ability to engage senior leaders, regulators, partners, and Board-level audiences.

•       Proven ability to lead transformation, build high-performing teams, make sound risk-based decisions, and operate effectively in a fast-paced, cross-functional, remote-enabled environment.

•       High ethical standards, strong judgment, attention to detail, and commitment to data integrity, accountability, and continuous improvement.

•       Ability to travel up to 25%, including international travel as needed.