Senior Director, GCP Quality & Inspection Excellence

Vertex Pharmaceuticals; Boston (MA); Sur place; USD 180 000 - 260 000; Plein temps

Résumé du poste

Vertex Pharmaceuticals in Boston seeks a Sr. Director, GCP Operational Quality to provide strategic direction and oversight of quality risk management, inspection readiness and real-time quality oversight across discovery and development programs.

This role leads Quality by Design, RBQM and the integrated GCP QMS, partnering with QA, audit, vendor management and cross-functional teams to drive sustainable quality outcomes and proactive risk mitigation throughout the product lifecycle.

Responsabilités

• Provides strategic direction and oversight to quality risk management and inspection readiness across program areas.
• Design program-specific Quality strategy with cross-functional alignment across Global Clinical Operations, Medical Affairs, Regulatory, etc.
• Leads risk-based approaches to quality for clinical development programs (Quality by Design, RBQM) and ensures effectiveness of risk monitoring and mitigation.
• Oversees development, implementation and maintenance of quality plans summarizing the results of quality activities.
• Leads quality working groups to define integrated plans across QA functions (audit, operations, vendor management, inspection readiness).
• Engages business partners to advance proactive quality approaches and developing new models, technologies and practices.
• Serves as Quality representative to cross-functional clinical development teams and governance bodies as applicable.
• Manages for cause, critical and/ or complex quality issues for strategic leadership of proactive inspection readiness.

Description du poste

Vertex Pharmaceuticals in Boston seeks a Sr. Director, GCP Operational Quality to provide strategic direction and oversight of quality risk management, inspection readiness and real-time quality oversight across discovery and development programs.

This role leads Quality by Design, RBQM and the integrated GCP QMS, partnering with QA, audit, vendor management and cross-functional teams to drive sustainable quality outcomes and proactive risk mitigation throughout the product lifecycle.