Senior Quality Operations Lead - Shift (Cell Therapy)

Vertex Pharmaceuticals; Boston (MA); On-site; USD 153,900 - 230,900; Full time

Job summary

Vertex Pharmaceuticals seeks an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in Boston. You will oversee deviations, investigations and CAPAs, ensuring inspection readiness and regulatory compliance across shifts while partnering with Manufacturing, QA and MSAT teams.

The role requires strong leadership, deep cGMP knowledge, and experience with quality systems and data analytics to drive continuous improvement on the shop floor.

Qualifications

• Bachelor's degree in biology, microbiology, chemistry, pharmaceutical sciences, engineering or related field is required.
• Master's degree or relevant comparable background preferred.
• 8+ years of relevant industry experience in biotech/pharma manufacturing or quality.
• 5+ years supporting aseptic manufacturing, sterile operations or parenteral production.
• Prior people leadership or supervisory experience is preferred.
• Experience with shop floor QA oversight in commercial or late-stage clinical manufacturing.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations including formulation, filling and inspection.
• Ensure activities comply with cGMP, GDP, site procedures and aseptic standards.
• Serve as primary quality representative for escalating critical quality issues.
• Support batch disposition readiness through review of documents and observations.
• Utilize MES, LIMS, eQMS and analytics for quality oversight and improvement.
• Lead deviation triage, investigations, CAPA development and close-out.

Skills

cGMP regulations

Aseptic processing

Deviation management

CAPA investigation

Data analytics

Lean Six Sigma

Quality risk management

Team leadership

Communication

Education

Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline

Master's degree preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Vertex Pharmaceuticals seeks an Associate Director, Shift Quality Operations to lead real-time QA on aseptic cell therapy manufacturing on-site in Boston. You will oversee deviations, investigations and CAPAs, ensuring inspection readiness and regulatory compliance across shifts while partnering with Manufacturing, QA and MSAT teams.

The role requires strong leadership, deep cGMP knowledge, and experience with quality systems and data analytics to drive continuous improvement on the shop floor.