QA Associate Director, Cell & Gene Therapy (Hybrid)

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

Benefits offered by this job

Medical, dental and vision benefits

Generous paid time off

Educational assistance programs

Student loan repayment

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex Pharmaceuticals Inc seeks an Associate Director for Manufacturing Process & Technical Quality to provide end-to-end QA oversight across cell and gene therapies from development through post-approval. You will establish quality standards, lead lifecycle governance, and ensure alignment with regulatory expectations while safeguarding patient safety and product quality.

The role partners with Manufacturing, Technical Operations, Regulatory Affairs and Quality to drive risk management,

Qualifications

• Bachelor’s degree in scientific or allied health field or equivalent.
• 8+ years of experience in a regulated pharmaceutical environment.
• Master’s degree preferred.

Responsibilities

• Oversee QA for product and process lifecycle, including tech transfers, validations, and new product introductions.
• Support regulatory submissions, inspections, deviation investigations and change controls.
• Partner with Manufacturing, Technical Operations, Regulatory Affairs, and Quality to drive continuous improvement and lifecycle governance.

Skills

GxP QA

Regulatory knowledge

MES/LIMS/eQMS

Root Cause Analysis

Cross-functional leadership

Education

Bachelor’s degree in scientific field

Master’s degree preferred

Tools

MES

LIMS

eQMS

Data visualization

Advanced analytics

Job description

Vertex Pharmaceuticals Inc seeks an Associate Director for Manufacturing Process & Technical Quality to provide end-to-end QA oversight across cell and gene therapies from development through post-approval. You will establish quality standards, lead lifecycle governance, and ensure alignment with regulatory expectations while safeguarding patient safety and product quality.

The role partners with Manufacturing, Technical Operations, Regulatory Affairs and Quality to drive risk management,