Vice President, Quality Assurance

Vice President Quality Assurance

SUMMARY

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. This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Develop and execute the company's quality assurance strategy aligned with business goals and regulatory expectations.
• Provide QA oversight from preclinical through commercial stages of cell and gene therapy products.
• Collaborate with R&D, patient supply, manufacturing, and regulatory teams to ensure quality is embedded throughout the product lifecycle and patient journey.
• Serve as the primary quality representative to executive leadership and regulatory agencies.
• Assess, scale, and continuously improve GxP-compliant Quality Management System (QMS)
• Ensure compliance with FDA, EMA, MHRA, and other global regulatory bodies.
• Ensure inspection readiness at all times and execution of an effective self-inspection program to drive continuous improvement.

QUALIFICATIONS

• Bachelor's or advanced degree in life sciences, biotechnology, or related field.
• 15+ years of experience in quality assurance within the biopharmaceutical industry, with at least 8 years in a senior leadership role.
• Deep knowledge of cell and gene therapy manufacturing and regulatory requirements.
• Proven track record of successful regulatory inspections and product approvals.
• Strong leadership, communication, and cross-functional collaboration skills.
• Experience with viral vectors (AAV, lentivirus), autologous/allogeneic cell therapies.
• Familiarity with electronic quality management systems (eQMS).
• Six Sigma or Lean Quality certification is a plus.