Inspection-Ready CMC Quality Leader

Vertex Pharmaceuticals; Boston (MA); Hybrid; USD 184,600 - 277,000; Full time

Job summary

Vertex Pharmaceuticals seeks a CMC Quality Compliance Director to lead inspection readiness and compliance for internal and external GMP sites. You will drive governance, risk-based strategies, and a high-quality culture across manufacturing and testing operations in support of Vertex's portfolio.

The role requires extensive GMP know-how, strategic leadership, and collaboration with cross-functional teams. This hybrid/on-site eligible position emphasizes scalable programs and staff development.

Qualifications

• Expert knowledge of global GMP requirements across multiple GxP areas.
• Ability to evaluate quality matters using a risk-based approach.
• Strong facilitation, communication, and coaching skills with leadership experience.

Responsibilities

• Accountable for inspection readiness and compliance programs across all GMP areas including external CMOs and internal sites.
• Monitor and interpret cGMP regulatory guidelines and trends and incorporate into phase-appropriate control strategies.
• Oversee internal and external sites, identify compliance risks, and implement action plans to improve quality culture.
• Monitor the health of the inspection readiness and management system and report to leadership.
• Collaborate across quality and functional areas to ensure scalable inspection programs, including new modalities.
• Provide technical and strategic support to all areas and serve as change agent for improvements.
• Lead and coach staff with enterprise-level thinking and direction.

Skills

GMP knowledge

Cross-functional collaboration

Risk-based decision making

GMP inspection management

Quality governance

Communication and coaching

Education

Bachelor's degree in a scientific or allied health field

10+ years of work experience with 3+ years of management

Job description

Vertex Pharmaceuticals seeks a CMC Quality Compliance Director to lead inspection readiness and compliance for internal and external GMP sites. You will drive governance, risk-based strategies, and a high-quality culture across manufacturing and testing operations in support of Vertex's portfolio.

The role requires extensive GMP know-how, strategic leadership, and collaboration with cross-functional teams. This hybrid/on-site eligible position emphasizes scalable programs and staff development.