Director of Global Quality Systems

1 week ago


Boston, Massachusetts, United States Vertex Pharmaceuticals Full time
Job Title: Director, Global Quality Systems

Vertex Pharmaceuticals is seeking a highly skilled and experienced Director, Global Quality Systems to provide strategic leadership and direction in the design, oversight, and effectiveness of the Vertex Quality Management System (QMS).

Key Responsibilities:
  • Oversee and ensure deployment of the Quality Management System framework
  • Actively champion and technically guide QA and operating staff to translate strategy into results
  • Engage the organization through direct line-of-sight of their work to Vertex's V/S/M and QMS design, deployment, effectiveness, and continual improvement
  • Develop and implement comprehensive quality strategies to ensure Vertex QMS meets regulatory requirements across Vertex programs
  • Provide leadership, coordination, and direction to benchmarking with external peers and industry for establishing best practices, emerging trends, and projection of future industry
Requirements:
  • Broad and deep regulatory compliance experience (e.g. ISO 13485, FDA 21 CFR 820 QSR, EU MDR) and quality operations experience (across multiple GxP areas and modalities)
  • Demonstrated experience in design, management, and improvement of global quality management systems (QMS); must have medical device experience
  • Regulatory inspection management experience
  • Broad and deep operational and project management knowledge and experience
  • Proven ability to design/evolve and/or implement KPIs that are fit-for-purpose manner enabling effectiveness and assessment of the health of the global QMS
Preferred Education and Experience:
  • M.S. (or equivalent degree) and 10+ years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 12+ years of relevant work experience, or relevant comparable background

Vertex is an equal employment opportunity and non-discrimination employer. We are committed to creating a diverse and inclusive work environment.



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