CMC Quality & Inspection Readiness Leader

Vertex Pharmaceuticals Inc (US)

United States

Híbrido

USD 148.000 - 221.000

Jornada completa

14 días+

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Ventajas ofrecidas por este puesto de trabajo

Annual bonus
Equity awards
Educational assistance (student loan)
Commuting subsidy
401(k)
Paid time off
Medical, dental and vision benefits

Descripción de la vacante

Vertex Pharmaceuticals Inc is seeking an Associate Director responsible for CMC Quality Compliance and Inspection Readiness across external sites, ensuring a state of readiness and robust quality culture.

The role leads cross-functional programs, drives issue identification and CAPA closures, and collaborates with global teams to optimize inspection processes and risk management. Travel up to 20% and hybrid work arrangements offered.

Formación

  • Regulatory knowledge and inspection expectations globally.
  • Strong improvement mindset with six sigma or lean methodologies.

Responsabilidades

  • Maintain inspection readiness and compliance programs for external operations.
  • Collaborate cross-functionally to achieve state of readiness for sites.
  • Identify gaps, assess risks, and drive CAPA closures.
  • Report readiness status to leadership and governance forums.

Conocimientos

Regulatory knowledge
Inspection management
Risk assessment
Six Sigma / Lean
Cross-functional leadership

Educación

Bachelor's degree in science

Descripción del empleo

Vertex Pharmaceuticals Inc is seeking an Associate Director responsible for CMC Quality Compliance and Inspection Readiness across external sites, ensuring a state of readiness and robust quality culture.

The role leads cross-functional programs, drives issue identification and CAPA closures, and collaborates with global teams to optimize inspection processes and risk management. Travel up to 20% and hybrid work arrangements offered.

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