Senior Director, GCP Quality & Operational Excellence

Biopharma Careers; Boston (MA); Hybrid; USD 218,000 - 326,000; Full time

Job summary

Vertex is seeking a Sr. Director, GCP Operational Quality to lead the strategic quality risk management across clinical programs with emphasis on inspection readiness and real-time risk mitigation.

This role partners with QA, regulatory, R&D and vendor management to ensure robust quality by design and continuous improvement, supporting lifecycle risk oversight and program milestones. The candidate will drive integrated QMS enhancements, lead quality reviews, and oversee cross-functional teams to

Qualifications

• MS or equivalent degree; 10+ years in QA/clinical operations
• Experience leading quality risk management in GCP environments
• Proven ability to design and implement risk-based quality systems

Responsibilities

• Provide strategic direction for quality risk management and inspection readiness
• Design and align quality strategies with stakeholders across GCP, QA, and regulatory
• Lead quality governance and assurance for programs across clinical development

Skills

Quality leadership

GxP risk management

Inspection readiness

Cross-functional collaboration

Strategic planning

Change management

Data analysis

Education

MS in a scientific field

15+ years of relevant experience

Tools

QMS knowledge

Job description

Vertex is seeking a Sr. Director, GCP Operational Quality to lead the strategic quality risk management across clinical programs with emphasis on inspection readiness and real-time risk mitigation.

This role partners with QA, regulatory, R&D and vendor management to ensure robust quality by design and continuous improvement, supporting lifecycle risk oversight and program milestones. The candidate will drive integrated QMS enhancements, lead quality reviews, and oversee cross-functional teams to