Global CMC Quality & Compliance Director

Regulatory Jobs; Boston (MA); Híbrido; USD 185 000 - 277 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work arrangement

Travel opportunities 5-10%

Resumo da oferta

Vertex is seeking a CMC Quality Compliance Director to lead inspection readiness and compliance across GMP sites, including external CMOs and internal manufacturing. You will drive risk-based governance and strategic improvements to quality systems.

The role requires a Bachelor's in science and approximately 10 years of experience with 3 years in management, plus hybrid/on-site flexibility to advance quality culture across the organization.

Qualificações

• Bachelor's degree in a scientific or allied health field.
• Typically requires 10 years of work experience and 3 years of management experience.

Responsabilidades

• Accountable for inspection readiness across GMP sites and programs.
• Monitor cGMP regulatory guidelines and implement phase-appropriate strategies.
• Oversee internal and external sites with cross-functional teams to improve compliance and quality culture.
• Monitor health of the inspection readiness system and report to leadership.
• Ensure the inspection program is scalable and integrates new modalities.
• Provide technical and strategic support to all areas for compliance decisions.
• Lead, develop, and coach staff and drive enterprise-level strategy.

Conhecimentos

Global GMP knowledge

Cross-functional leadership

Risk-based decision making

GxP governance

Quality culture improvement

Facilitation and coaching

Formação académica

Bachelor's degree in a scientific or allied health field

Descrição da oferta de emprego

Vertex is seeking a CMC Quality Compliance Director to lead inspection readiness and compliance across GMP sites, including external CMOs and internal manufacturing. You will drive risk-based governance and strategic improvements to quality systems.

The role requires a Bachelor's in science and approximately 10 years of experience with 3 years in management, plus hybrid/on-site flexibility to advance quality culture across the organization.