CMC Quality & Inspection Readiness Lead

Vertex Pharmaceuticals LLC; Boston, Northern (MA, KY); Hybrid; USD 148,000 - 221,000; Full time

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness in Boston for a hybrid role. You will lead external-site inspection readiness and drive continuous improvement across programs and sites.

The role requires strong regulatory knowledge, 8+ years of experience, and proven leadership in quality compliance with cross-functional teams. Hybrid-Eligible with travel up to 10-20% and a competitive compensation package.

Qualifications

• Bachelor's degree in a scientific discipline, or allied health field or equivalent degree.
• 8+ years of relevant experience.
• Knowledge of regulatory requirements and inspection expectations globally.

Responsibilities

• Responsible for inspection readiness and compliance programs for external operations.
• Drive identification and resolution of issues, gaps and risks through assessments, audits and trend evaluations.
• Oversee inspection execution including responses and closure of CAPAs.

Skills

Inspection management

Risk management

Cross-functional collaboration

Facilitation & coaching

Regulatory knowledge

Project leadership

Six Sigma/Lean

Education

Bachelor's degree in a scientific discipline

Job description

Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness in Boston for a hybrid role. You will lead external-site inspection readiness and drive continuous improvement across programs and sites.

The role requires strong regulatory knowledge, 8+ years of experience, and proven leadership in quality compliance with cross-functional teams. Hybrid-Eligible with travel up to 10-20% and a competitive compensation package.