Associate Director, CMC Quality & Inspection Readiness

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

Job summary

Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness, to lead inspection readiness for external sites and drive global quality programs. You will work cross-functionally to identify risks, resolve CAPAs, and champion continuous improvement initiatives across modalities.

The role requires a Bachelor's degree in a science field and 8+ years of relevant experience, with hybrid/on-site flexibility and up to 10-20% travel.

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.
• Experience in multiple modalities preferred.
• Strong knowledge of inspection management and risk management.
• Lean six sigma or other continuous improvement experience.
• Ability to lead improvement projects and cross-functional teams.

Responsibilities

• Responsible for inspection readiness and compliance programs for external operations.
• Collaborates across functions and with external sites to maintain inspection readiness.
• Drive identification and resolution of issues, gaps, and risks through audits and trend analysis.
• Oversee inspection execution including responses and closure of CAPAs.
• Foster collaboration and knowledge sharing; develop trusted partnerships with external sites.
• Report inspection readiness status to leadership and governance forums.

Skills

Inspection management

Risk management

Continuous improvement

Facilitation

Communication skills

Leadership

Performance metrics

Education

Bachelor's degree in a scientific discipline

8+ years of experience

Job description

Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness, to lead inspection readiness for external sites and drive global quality programs. You will work cross-functionally to identify risks, resolve CAPAs, and champion continuous improvement initiatives across modalities.

The role requires a Bachelor's degree in a science field and 8+ years of relevant experience, with hybrid/on-site flexibility and up to 10-20% travel.