Associate Director, Shift Quality Ops - Cell Therapy

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

Job summary

Vertex Pharmaceuticals Incorporated in Boston, MA is seeking an Associate Director – Shift Quality Operations to provide quality leadership across manufacturing shifts for cell therapy operations, ensuring cGMP compliance and aseptic processing standards.

You will lead a team of quality professionals, partner with manufacturing, QA, MSAT, and Engineering to support batch execution, deviations, investigations, and continuous improvement on site at Vertex's VMC.

Qualifications

• Minimum 8+ years in manufacturing quality in biotech/pharma environments.
• Bachelor's degree required; master's preferred.
• Experience with shop-floor QA oversight and aseptic operations.

Responsibilities

• Provide shift-based QA oversight for aseptic manufacturing, ensuring cGMP and aseptic standards.
• Lead deviation triage, investigations, and CAPA to ensure timely closure.
• Lead and develop a team of shift quality professionals.
• Support inspection readiness and regulatory audits.
• Collaborate cross-functionally with Manufacturing, QA, MSAT, Engineering, Validation, and Supply Chain.

Skills

QA leadership

cGMP compliance

Aseptic processing

Quality risk management

Data analytics

LEAN Six Sigma

Education

Bachelor's degree in Biology, Microbiology, Chemistry, Pharmaceutical Sciences, Engineering, or related discipline

Master's degree preferred

Tools

MES

LIMS

eQMS

Job description

Vertex Pharmaceuticals Incorporated in Boston, MA is seeking an Associate Director – Shift Quality Operations to provide quality leadership across manufacturing shifts for cell therapy operations, ensuring cGMP compliance and aseptic processing standards.

You will lead a team of quality professionals, partner with manufacturing, QA, MSAT, and Engineering to support batch execution, deviations, investigations, and continuous improvement on site at Vertex's VMC.