CMC Quality & Inspection Readiness Lead

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 drive inspection readiness and compliance for external sites. The role collaborates across functions and sites to maintain quality culture and address risks through audits and CAPA closures.

The position demands deep regulatory knowledge, experience with multiple modalities, and proven leadership in quality improvement projects, enabling continuous operational excellence in a global

Qualifications

• Bachelor's degree in a scientific discipline or allied health field.
• 8 years of relevant experience in quality/compliance or related areas.
• Knowledge of global regulatory requirements and inspection expectations.
• Experience leading cross-functional improvement projects.

Responsibilities

• Ensure inspection readiness and compliance programs for external operations.
• Collaborate cross-functionally to maintain state of readiness across sites.
• Identify and resolve issues, gaps, and risks via audits and trend analysis.
• Oversee inspection execution including responses and closure of CAPAs.

Skills

Regulatory knowledge

Inspection management

Six Sigma/Lean

Facilitation/coaching

Cross-functional leadership

Performance metrics analysis

Education

Bachelor's degree in a scientific discipline

Job description

Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to drive inspection readiness and compliance for external sites. The role collaborates across functions and sites to maintain quality culture and address risks through audits and CAPA closures.

The position demands deep regulatory knowledge, experience with multiple modalities, and proven leadership in quality improvement projects, enabling continuous operational excellence in a global