CMC Quality & Inspection Readiness Lead

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

Benefits offered by this job

Comprehensive benefits

Commuting subsidy

Educational assistance

Job summary

Vertex Pharmaceuticals Incorporated seeks an Associate Director, CMC Quality Compliance and Inspection Readiness, to lead inspection readiness and compliance for external sites and drive quality culture across operations.

The role requires coordinating with multiple functions, managing CAPAs, and implementing continuous improvement initiatives, including lean practices. Hybrid-eligible with travel up to 20% and a base salary in the posted range.

Qualifications

• Knowledge of regulatory requirements and inspection expectations globally.
• Experience with inspection management and risk assessment across multiple modalities.
• Strong continuous improvement experience (Six Sigma or Lean).
• Proven ability to lead projects and cross-functional teams; excellent facilitation and coaching.

Responsibilities

• Maintain inspection readiness for external operations and ensure sites stay in a state of readiness.
• Identify and resolve issues, gaps, and risks through audits, assessments, and trend evaluation.
• Oversee inspection execution, including responses and closure of CAPAs.
• Foster collaboration across functions and external sites to drive improvement and knowledge sharing.

Skills

Regulatory knowledge

Inspection management

Risk management

Six Sigma/Lean

Project leadership

Facilitation/Coaching

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline or allied health field

Job description

Vertex Pharmaceuticals Incorporated seeks an Associate Director, CMC Quality Compliance and Inspection Readiness, to lead inspection readiness and compliance for external sites and drive quality culture across operations.

The role requires coordinating with multiple functions, managing CAPAs, and implementing continuous improvement initiatives, including lean practices. Hybrid-eligible with travel up to 20% and a base salary in the posted range.