Shift Quality Ops Director Cell Therapy Manufacturing

Biopharma Careers; Boston (MA); On-site; USD 154,000 - 231,000; Full time

Job summary

Vertex is seeking an Associate Director - Shift Quality Operations to provide senior QA leadership for aseptic cell therapy manufacturing at the VMC site. You will ensure cGMP compliance across shifts and leverage MES/LIMS/eQMS tools for real-time quality oversight.

You will lead a quality team, manage deviations and CAPAs, and partner with Manufacturing, MSAT, Validation, and Supply Chain to enable safe, reliable production and continuous improvement, while staying inspection-ready.

Qualifications

• 8+ years in biotech/regulated pharmaceutical environment
• 5+ years supporting aseptic manufacturing or parenteral production
• Prior people leadership or supervisory experience preferred
• Experience with shop floor QA oversight in a commercial or late-stage clinical setting

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations across formulation, filling, and inspection activities.
• Ensure activities comply with cGMP, GDP, site procedures, and aseptic standards.
• Lead or support deviation triage, investigation, and CAPA development.
• Mentor and develop a team of shift quality professionals; ensure coverage and effective handoffs.
• Maintain inspection readiness and support internal audits, regulatory inspections, and client audits.

Skills

cGMP regulations

Aseptic processing

Quality systems

Root Cause Analysis

Data analytics

Education

Bachelor's degree in Biology/Microbiology/Chemistry/Pharmaceutical Sciences/Engineering

Master's degree preferred

Job description

Vertex is seeking an Associate Director - Shift Quality Operations to provide senior QA leadership for aseptic cell therapy manufacturing at the VMC site. You will ensure cGMP compliance across shifts and leverage MES/LIMS/eQMS tools for real-time quality oversight.

You will lead a quality team, manage deviations and CAPAs, and partner with Manufacturing, MSAT, Validation, and Supply Chain to enable safe, reliable production and continuous improvement, while staying inspection-ready.