SVP, Global Quality Assurance

Regulatory Jobs; Durham (NC); In loco; USD 250.000 - 360.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

GxP leadership

Quality strategy

Regulatory knowledge

Executive communication

Formazione

Master's degree in science

Strumenti

QMS platforms

Descrizione del lavoro

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

JOB SUMMARY:

The SVP, Global Quality Assurance provides enterprise leadership for BioCryst’s global Quality organization and GxP Quality strategy across development, clinical, commercial, distribution, and post‑market operations. This role defines and advances a fit-for-purpose Quality vision, culture, and Quality Management System that enable compliant, scalable, and reliable execution while serving as a competitive advantage for BioCryst. Working closely with the executive leadership team and key cross‑functional partners, the SVP drives inspection readiness, risk‑based decision‑making, continuous improvement, and digital and AI‑enabled modernization of the QMS.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• 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.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.