GCP Quality & Inspection Readiness Leader

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 218,000 - 326,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Sr. Director, GCP Operational Quality to provide strategic direction and oversight of risk-based quality management across clinical programs.

You will lead a cross-functional team to ensure inspection readiness and robust quality systems aligned with program milestones. The role requires deep GCP/QA expertise, strong leadership and collaboration with audit, vendor management and regulatory partners to advance quality by design and proactive risk

Qualifications

• MS (or equivalent) with 10+ years of relevant experience, or BS with 15+ years of relevant experience.
• Deep GCP/QA knowledge and regulatory familiarity.
• Proven leadership in quality strategy and operational planning.

Responsibilities

• Provide strategic direction for risk-based quality management across programs.
• Lead development and execution of quality plans and RBQM strategies.
• Oversee Quality by Design and inspection readiness across clinical development.
• Collaborate with audit, vendor management, and regulatory partners.

Skills

Quality leadership

GCP Knowledge

Risk management

RBQM

Inspection readiness

Quality governance

Stakeholder collaboration

Education

MS or equivalent

BS in scientific field

Job description

Vertex Pharmaceuticals Incorporated is seeking a Sr. Director, GCP Operational Quality to provide strategic direction and oversight of risk-based quality management across clinical programs.

You will lead a cross-functional team to ensure inspection readiness and robust quality systems aligned with program milestones. The role requires deep GCP/QA expertise, strong leadership and collaboration with audit, vendor management and regulatory partners to advance quality by design and proactive risk