Shift Quality Operations Leader – Cell Therapy

Vertex Inc.; Boston (MA); On-site; USD 154,000 - 231,000; Full time

Job summary

Vertex is seeking an Associate Director – Shift Quality Operations to lead QA oversight for cell therapy manufacturing on-site at Vertex’s VMC. You will partner with Manufacturing, QA, QC, MSAT, Engineering, Validation and Supply Chain to ensure cGMP compliance, aseptic processing, deviation management, and timely batch disposition.

The role manages a quality team across shifts, using MES/LIMS/eQMS and data analytics to enable real-time quality decisions, inspection readiness, CAPA, risk

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 and related activities.
• 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 manufacturing documentation and quality observations.
• Demonstrate understanding of digital quality systems and analytics within regulated environments.
• Use MES, LIMS, and eQMS for quality oversight.

Skills

Shift QA oversight

cGMP knowledge

Aseptic processing

Quality systems

Data analytics

Root Cause Analysis

LEAN / Six Sigma

Leadership

Communication

Education

Bachelor’s degree in Biology/biotechnology/related field

Master’s degree preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Vertex is seeking an Associate Director – Shift Quality Operations to lead QA oversight for cell therapy manufacturing on-site at Vertex’s VMC. You will partner with Manufacturing, QA, QC, MSAT, Engineering, Validation and Supply Chain to ensure cGMP compliance, aseptic processing, deviation management, and timely batch disposition.

The role manages a quality team across shifts, using MES/LIMS/eQMS and data analytics to enable real-time quality decisions, inspection readiness, CAPA, risk