Associate Director: CMC Quality & Inspection Readiness

Regulatory Jobs; Boston (MA); Híbrido; USD 148 000 - 221 000; Tempo integral

Resumo da oferta

Vertex is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to lead inspection readiness programs across external sites, drive continuous improvement, and partner across functions to sustain regulatory compliance and a strong quality culture.

The role requires a bachelor’s degree in a scientific discipline and 8+ years of relevant experience, with up to 20% travel; hybrid-eligible or on-site options are available.

Qualificações

• Knowledge of regulatory requirements and inspection expectations globally.
• Experience in multiple modalities preferred.
• Strong technical knowledge including inspection management and risk management.
• Continuous improvement experience such as six sigma or lean.
• Proven ability to lead improvement projects and project teams and organize various teams and forums.
• Superb facilitation, communication, and coaching/influencing skills with proven ability to lead teams.
• Proven ability to identify and analyze performance indicators.

Responsabilidades

• Responsible for inspection readiness and compliance programs for external operations.
• Drive identification and resolution of issues, gaps and risks through collaboration with operational areas, assessments, audits, and evaluation of trends.
• Support and oversee inspection execution including responses and closure of CAPAs.
• Collaboration and Integration: Serve as an integrator across multiple functions, fostering collaboration and knowledge sharing.
• Drive optimization, continuous improvement, and operational excellence to enhance processes.
• Report inspection readiness status including risks to leadership and governance forums

Conhecimentos

Regulatory knowledge

Cross-functional collaboration

Inspection management

Risk management

Continuous improvement

Facilitation / coaching

Performance indicators analysis

Formação académica

Bachelor's degree in a scientific discipline

8+ years of relevant experience

Descrição da oferta de emprego

Vertex is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to lead inspection readiness programs across external sites, drive continuous improvement, and partner across functions to sustain regulatory compliance and a strong quality culture.

The role requires a bachelor’s degree in a scientific discipline and 8+ years of relevant experience, with up to 20% travel; hybrid-eligible or on-site options are available.