Quality Director, Manufacturing Process (Hybrid)

Company: Vertex Pharmaceuticals
Location: Boston
Posted on: April 29, 2025

Job Description:

Quality Director, Manufacturing Process (Hybrid)
Apply locations: Boston, MA - Full time - Posted 30+ Days Ago - Job Requisition ID: REQ-24585
Job Description
The Quality Director - Manufacturing Process will lead operational excellence efforts to identify and drive improvements across CGT Quality operations by implementing industry best practices, methodologies, and systems aimed at risk-based compliance and efficient quality operations. The role requires a strategic leader with extensive experience in quality management, operational excellence, and change management to foster a culture of continuous improvement.
This role involves developing, leading, and implementing process improvements and developing performance metrics with cross-functional partners.
Key Duties and Responsibilities:

• Lead the development and execution of the organization's quality and operational excellence strategy, ensuring alignment with overall business goals.
  
• Critically analyze and assess current Quality operational processes to identify areas for improvement and simplification.
  
• Leverage industry best methodologies such as Lean Six Sigma or other operational excellence methodologies to drive efficiencies in Quality operations.
  
• Utilize critical thinking to assess and compare processes across various CDMOs to drive consistency and continuous improvements in Batch Record creation.
  
• Cross-Functional Collaboration: Work closely with senior leadership and cross-functional partners such as External Manufacturing, QC, MSAT to drive quality initiatives, troubleshoot operational challenges, and optimize processes.
  
• Data-Driven Decision Making: Analyze operational performance data and KPIs to identify trends and implement solutions for improving quality and efficiency.
  
• Change Management: Champion efforts to ensure successful adoption of new tools, processes, and systems to meet quality and operational objectives.
  
  Knowledge and Skills:
  
  
• In-depth global regulatory agency knowledge and experience across GXP lifecycle in Cell & Gene therapy and/or Biologics.
  
• Experience in product lifecycle from discovery to commercial product development.
  
• Broad technical knowledge in manufacturing operations.
  
• Skills:
  

• 
  
• Strong leadership and communication skills.
  
• Expertise in Lean, Six Sigma, or similar methodologies.
  
• Results-driven execution and tracking.
  
• Experience in process mapping and root cause analysis.
  
• Ability to lead and inspire cross-functional teams.
  
• Experience with quality management software and ERP systems.
  
• Critical thinking skills and attention to detail.
  
  
  
• Ability to thrive in a fast-paced environment.
  
• Strong interpersonal skills to lead projects and engage stakeholders.
  
• Change management and organizational development experience.
  
  Education and Experience:
  
  
• Education: Bachelor's degree in engineering, Biomedical engineering, or related scientific field.
  
• Certifications: Six Sigma Black Belt, Lean Certification, or equivalent.
  
• Experience: 10+ years in quality management and continuous improvement roles with leadership and process optimization experience.
  
  Additional Information:
  Role offers flexibility: Hybrid (up to two days remote) or On-Site (five days/week with ad hoc flexibility).
  Pay Range: $182,400 - $273,500
  Benefits: Comprehensive benefits including medical, dental, vision, paid time off, educational assistance, 401(k), and more.
  Equal Opportunity Statement: Vertex is an equal opportunity employer committed to diversity and inclusion. Reasonable accommodations are available upon request.
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Keywords: Vertex Pharmaceuticals, Hartford , Quality Director, Manufacturing Process (Hybrid), Executive , Boston, Connecticut