R&D Quality Lead — GLP, Biomarkers & Research

Vertex Pharmaceuticals; Boston (MA); Híbrido; USD 215.000 - 322.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Paid time off

Educational assistance

Commuting subsidy

Charitable matching

401(k)

Descripción de la vacante

Vertex Pharmaceuticals is seeking a senior leader to own the end-to-end quality assurance strategy for proactive, risk-informed oversight of clinical evidence generation and product vigilance. You will drive regulatory compliance across Vertex processes and lead a diverse team across Research, GLP, Biomarker and IVD activities.

The role emphasizes strategic direction, governance, inspection readiness, and collaboration with functional leaders to protect data integrity and patient safety in a

Formación

• MS (or equivalent degree) and 10+ years of relevant work experience, or BS in a scientific or allied health field and 15+ years of relevant work experience.
• Experience leading QA strategy and regulatory compliance across research, GLP, and clinical development.

Responsabilidades

• Serves as strategic partner to functional leaders across product modalities ensuring quality/compliance oversight of processes and data integrity.
• Defines strategy and oversees tactical execution to provide effective oversight of research, GLP studies, and vendor governance.
• Leads an operational quality team to identify and remediate potential compliance issues and improve processes.
• Oversees communication of quality metrics, trends, and insights to leadership and external forums.

Conocimientos

Strategic leadership

Quality assurance

Regulatory compliance

Educación

MS or equivalent degree

BS in scientific/allied health field

Descripción del empleo

Vertex Pharmaceuticals is seeking a senior leader to own the end-to-end quality assurance strategy for proactive, risk-informed oversight of clinical evidence generation and product vigilance. You will drive regulatory compliance across Vertex processes and lead a diverse team across Research, GLP, Biomarker and IVD activities.

The role emphasizes strategic direction, governance, inspection readiness, and collaboration with functional leaders to protect data integrity and patient safety in a