Offer summary

Qualifications:

Bachelor’s or advanced degree in life sciences, biotechnology, or related field., At least 15 years of experience in quality assurance within the biopharmaceutical industry., Minimum of 8 years in a senior leadership role., Deep knowledge of cell and gene therapy manufacturing and regulatory requirements..

Key responsibilities:

Develop and implement the company's quality assurance strategy.

Oversee QA activities from preclinical to commercial stages of therapy products.

Collaborate with R&D, manufacturing, and regulatory teams to ensure quality throughout the product lifecycle.

Represent quality assurance to executive leadership and regulatory agencies.

Job description

About bluebird bio

At bluebird every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:

Persist for Purpose
Be Compassionate
Stay humble and curious
Keep it real
Celebrate (sm)all wins

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

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.

bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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