Director, Product Quality - Biologics & Device (Hybrid)

Company Name

Vertex Pharmaceuticals

Job Overview

The Director, Product Quality is accountable for end-to-end quality oversight of Biologics and Combination Device programs throughout clinical development, commercialization, filing, approval, launch, and post-approval lifecycle management.

Responsibilities

• Setting quality strategies, standards, and control requirements.
• Ensuring alignment with regulatory expectations.
• Identifying and mitigating product quality risks.

Requirements

• Bachelor's/Master's degree.
• 10+ years of industry experience in quality/regulatory roles.
• 5+ years of leadership experience.
• Expertise in Biologics and Combination Device cGMP compliance.