Senior Shift Quality Operations Lead - Cell Therapy

Regulatory Jobs; Boston (MA); Sur place; USD 154 000 - 231 000; Plein temps

Résumé du poste

Vertex is seeking an Associate Director for Shift Quality Operations on-site at its Vertex Manufacturing Campus (VMC). You will provide real-time quality leadership across shifts for cell therapy manufacturing, ensuring compliance with cGMP and aseptic processing while coordinating with Manufacturing, QA, QC, MSAT, Engineering, Validation, and Supply Chain.

You will lead a team of quality professionals, drive deviation investigations, TRIAGE, CAPA processes, and maintain inspection readiness on

Qualifications

• 8+ years in biotech/regulated pharma manufacturing quality roles
• 5+ years supporting aseptic manufacturing or parenteral production
• Experience leading shift QA oversight on shop floor
• Strong knowledge of cGMP, aseptic processing, and contamination control
• Experience with deviation/CAPA/investigation systems and QA data analytics
• Ability to drive continuous improvement and lead teams on quality readiness

Responsabilités

• Provide shift-based QA oversight for aseptic manufacturing operations
• Ensure compliance with cGMP, GDP, procedures and aseptic standards
• Lead or support deviation triage, investigations, and CAPA development
• Manage and develop a team of shift quality professionals
• Maintain inspection readiness and support regulatory inspections
• Collaborate cross-functionally to support product quality and operational excellence

Connaissances

QA Leadership

GxP Compliance

Aseptic Processing

cGMP

Data Analytics

Root Cause Analysis

Formation

Bachelor’s degree in Biology/Pharmaceutical Sciences/Engineering

Master’s degree preferred

Outils

MES

LIMS

eQMS

Description du poste

Vertex is seeking an Associate Director for Shift Quality Operations on-site at its Vertex Manufacturing Campus (VMC). You will provide real-time quality leadership across shifts for cell therapy manufacturing, ensuring compliance with cGMP and aseptic processing while coordinating with Manufacturing, QA, QC, MSAT, Engineering, Validation, and Supply Chain.

You will lead a team of quality professionals, drive deviation investigations, TRIAGE, CAPA processes, and maintain inspection readiness on