Vice President, Quality Assurance - Remote

Overview

We are seeking a Vice President of Quality Assurance to lead and oversee all aspects of quality assurance across the organization, with a focus on cell and gene therapy products. This role ensures compliance with global regulatory requirements (FDA, EMA, etc.), drives a culture of quality, and supports the development, manufacturing, and commercialization of advanced therapies.

In Short

• Lead quality assurance for cell and gene therapy products.
• Ensure compliance with FDA, EMA, and global regulatory requirements.
• Develop and execute quality assurance strategy.
• Collaborate with R&D, manufacturing, and regulatory teams.
• Serve as quality representative to executive leadership.
• Continuously improve Quality Management System (QMS).
• Maintain inspection readiness at all times.
• 15+ years of experience in quality assurance.
• Strong leadership and collaboration skills required.
• Experience with viral vectors and eQMS is a plus.

Requirements

• Bachelor’s or advanced degree in life sciences or related field.
• 15+ years of experience in quality assurance.
• Deep knowledge of cell and gene therapy manufacturing.
• Proven track record of successful regulatory inspections.
• Strong leadership and communication skills.
• Experience with viral vectors and cell therapies.
• Familiarity with eQMS.
• Six Sigma or Lean Quality certification is a plus.

Benefits

• Opportunity to work with innovative gene therapies.
• Collaborative and respectful work environment.
• Focus on personal and professional growth.
• Inclusive and diverse company culture.