Senior Director, GCP Quality & Inspection Readiness

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

Job summary

Vertex Pharmaceuticals in Boston is seeking a Sr. Director, GCP Operational Quality to provide strategic direction for quality risk management across clinical programs and ensure real-time inspection readiness.

You will lead Quality Management Reviews and collaborate with QA, audit and vendor management to uphold compliance and proactive quality outcomes. The role requires applying Quality by Design and risk-based quality management across programs, with leadership across teams and partnerships.

Qualifications

• MS or equivalent degree with 10+ years in clinical quality.
• BS in scientific or allied health field with 15+ years of relevant experience.

Responsibilities

• Provide strategic direction and oversight of risk management across program areas.
• Lead Quality strategy development and align QA stakeholders for inspection readiness.

Skills

GCP Quality

RBQM

QbD

Strategic Planning

Leadership

Communication

Education

MS (or equivalent) + 10+ years

BS in scientific/health field + 15+ years

Job description

Vertex Pharmaceuticals in Boston is seeking a Sr. Director, GCP Operational Quality to provide strategic direction for quality risk management across clinical programs and ensure real-time inspection readiness.

You will lead Quality Management Reviews and collaborate with QA, audit and vendor management to uphold compliance and proactive quality outcomes. The role requires applying Quality by Design and risk-based quality management across programs, with leadership across teams and partnerships.