Manufacturing Process & Quality Lead - Gene Therapies

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 157,000 - 235,000; Full time

Job summary

Vertex Pharmaceuticals LLC is seeking a Manufacturing Process & Technical Quality Associate Director to provide end-to-end quality oversight for cell and gene therapy programs across development, commercialization, and post-approval lifecycle. The role ensures product quality standards align with regulatory expectations while mitigating risks and protecting patient safety.

The incumbent partners with Manufacturing, Technical Operations, Regulatory Affairs, and Quality to drive governance,

Qualifications

• Bachelors in science or related field; advanced degree preferred.
• Experience with GxP QA/QC in pharma/biotech.
• Exposure to digital manufacturing platforms and data analytics.

Responsibilities

• Provide QA SME oversight for product/process lifecycle from development to launch to post‑life management.
• Lead QA reviews of stage-gate deliverables, tech transfers, validations, and new product introductions.
• Develop and maintain quality frameworks aligned with regulatory expectations and CGT.
• Support regulatory inquiries, CAPAs, risk assessments, and inspections readiness.

Skills

QA oversight

GxP QA

Data analytics

Root Cause Analysis

Process improvement

Cross-functional

Digital manufacturing

AI in manufacturing

Education

Bachelor's degree in science

Master's degree in Business/Science

Tools

MES

LIMS

eQMS

Data visualization

AI tools

Job description

Vertex Pharmaceuticals LLC is seeking a Manufacturing Process & Technical Quality Associate Director to provide end-to-end quality oversight for cell and gene therapy programs across development, commercialization, and post-approval lifecycle. The role ensures product quality standards align with regulatory expectations while mitigating risks and protecting patient safety.

The incumbent partners with Manufacturing, Technical Operations, Regulatory Affairs, and Quality to drive governance,