Associate Director, Shift Quality Operations (Cell and Genetic Therapies)

Vertex Pharmaceuticals seeks an Associate Director for Shift Quality Operations to provide quality assurance leadership and oversight for cell therapy manufacturing. This role ensures cGMP compliance, manages regulatory expectations, leads a quality team on assigned shifts, and supports cross-functional manufacturing operations in Boston.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations including formulation, filling, and inspection
• Lead deviation triage, investigation, root cause analysis, and CAPA development to ensure timely closure
• Oversee quality execution for critical aseptic operations, contamination control, and cell therapy manufacturing processes
• Lead and develop a team of shift quality professionals with clear goals and performance expectations
• Partner with cross-functional teams to support production schedules, process improvements, and tech transfer activities

Requirements

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related field
• 8+ years of manufacturing, quality assurance, or quality control experience in biotechnology or regulated pharmaceutical environments
• 5+ years supporting aseptic manufacturing, sterile operations, or parenteral production
• Strong knowledge of cGMP regulations, aseptic processing principles, Annex 1, and contamination control
• Prior people leadership or supervisory experience strongly preferred
• Experience with Root Cause Analysis, data analytics, and operational excellence methodologies
• Proficiency with MES, LIMS, eQMS, and data visualization platforms in regulated environments

Compensation: $153,900 - $230,900 base