Shift Quality Ops Director - Cell Therapy

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

Benefits offered by this job

Annual bonus

Equity awards

Medical, dental, and vision benefits

Job summary

Vertex Pharmaceuticals Inc in Boston is seeking an Associate Director – Shift Quality Operations to lead quality leadership and oversight for cell therapy manufacturing across assigned shifts. The role focuses on ensuring cGMP compliance, aseptic processing, and site quality systems while enabling safe, reliable operations.

You will collaborate with Manufacturing, QA, QC, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviations, investigations, line clearance,

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline required.
• Preferred master’s degree or relevant comparable background.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations, including formulation, filling, inspection, and supporting activities.
• Oversee quality execution for critical aseptic operations, material flow and contamination control practices, line clearance, and cell therapy manufacturing.
• Lead or support deviation triage, investigation, root-cause analysis, impact assessments, and CAPA development.
• Lead, coach, and develop a team of shift quality professionals.
• Maintain constant inspection readiness for aseptic manufacturing areas.
• Partner with site leadership and cross-functional teams to support production schedule adherence and process improvements.

Skills

cGMP compliance

Aseptic processing

QA oversight

Data analytics

Root cause analysis

LEAN Six Sigma

Leadership

Regulatory inspection readiness

Education

Bachelor's in Biology/Pharmacy

Master's preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Vertex Pharmaceuticals Inc in Boston is seeking an Associate Director – Shift Quality Operations to lead quality leadership and oversight for cell therapy manufacturing across assigned shifts. The role focuses on ensuring cGMP compliance, aseptic processing, and site quality systems while enabling safe, reliable operations.

You will collaborate with Manufacturing, QA, QC, MSAT, Engineering, Validation, and Supply Chain to support batch execution, deviations, investigations, line clearance,