QA Analytics Leader, Cell & Gene Compliance (On-Site)

Vertex Pharmaceuticals; Boston (MA); On-site; USD 156,600 - 234,800; Full time

Job summary

Vertex Pharmaceuticals seeks an Associate Director, Analytical Quality Assurance to oversee QC and analytical development activities across Cell & Gene programs. You will drive QA oversight of method validations, transfers, and stability programs, while leading audits and CAPA processes to ensure FDA/EMA compliance.

The role emphasizes digital quality systems, data analytics, and collaboration with internal labs and external contract testing labs to maintain robust quality oversight throughout

Qualifications

• Advanced QA/QC knowledge in cell therapies and regulated environments.
• Experience with deviations, OOS/OOT investigations and CAPA.
• Evidence of leading audits/inspections by regulators.

Responsibilities

• Provide QA oversight of QC and analytical development activities.
• Lead QA review and approval of method validations and transfers.
• Oversee deviation investigations, CAPA, and change controls.
• Coordinate QA activities with internal labs and contract testing labs.

Skills

Quality Assurance

Analytical development

Root Cause Analysis

Data analytics

LEAN/Six Sigma

Regulatory knowledge

Communication skills

Problem solving

Education

Master's degree in science

PhD preferred

Tools

MES

LIMS

eQMS

Data visualization tools

Job description

Vertex Pharmaceuticals seeks an Associate Director, Analytical Quality Assurance to oversee QC and analytical development activities across Cell & Gene programs. You will drive QA oversight of method validations, transfers, and stability programs, while leading audits and CAPA processes to ensure FDA/EMA compliance.

The role emphasizes digital quality systems, data analytics, and collaboration with internal labs and external contract testing labs to maintain robust quality oversight throughout