Cell Therapy: Shift Quality Operations Lead

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

Benefits offered by this job

Annual bonus

Equity awards

Comprehensive benefits including PTO

Job summary

Vertex Pharmaceuticals Incorporated is seeking an Associate Director to provide shift-based QA oversight for aseptic manufacturing operations on-site at the VMC. You will lead quality leadership across manufacturing shifts, ensuring compliance with cGMP, GDP, and regulatory expectations while driving continuous improvement.

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

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline required.
• 8+ years of industry experience in biotechnology/regulated pharma.
• 5+ years supporting aseptic manufacturing or parenteral production.
• Strong knowledge of cGMP regulations and aseptic processing principles.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing operations (formulation, filling, inspection, etc.).
• Ensure activities comply with cGMP, GDP, site procedures, and aseptic standards.
• Lead or support deviation triage, investigations, CAPA development, and acceptance of quality events.
• Coach and develop a team of shift quality professionals; ensure shift coverage and handoffs.
• Support batch disposition readiness through review of manufacturing docs and events.
• Maintain inspection readiness and support regulatory inspections and audits.

Skills

Quality leadership

GxP compliance

Manufacturing ops

QA oversight

Aseptic processing

Data analytics

Team leadership

Regulatory knowledge

Education

Bachelor's degree in a relevant field

Master's degree preferred

Tools

MES

LIMS

eQMS

Data visualization

Advanced analytics

Job description

Vertex Pharmaceuticals Incorporated is seeking an Associate Director to provide shift-based QA oversight for aseptic manufacturing operations on-site at the VMC. You will lead quality leadership across manufacturing shifts, ensuring compliance with cGMP, GDP, and regulatory expectations while driving continuous improvement.

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