Director / Sr. Director, Quality Systems

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.

ABOUT US

We are seeking an experienced and strategic Director, Quality Systems to lead the commercial strategy and execution for our quality-focused biotech solutions. You will bridge the gap between product development, regulatory compliance, and customer engagement, driving growth for our quality systems portfolio in the biotech and life sciences sectors. You will bring a strong background in biotech or pharmaceutical quality systems (GMP, GCP, GLP), with proven commercial leadership experience in B2B environments. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Commercial Strategy & Execution:
  • Maintain and monitor the bbb overall QMS including KPIs / reporting for Management review responsibilities and risk management
  • Partner with IT on technology roadmap for eQMS and supporting systems (Oracle, Compliance Wire, Blue trace, etc)
  • Establish and maintain CI model for Quality processes

• Customer Engagement & Relationship Management:

• • Build strong relationships with key stakeholders, including quality, regulatory, and operations leaders within target organizations.
  • Partner with cross-functional teams to deliver tailored solutions that meet complex regulatory and quality compliance needs.
  • Collaborate with IT to ensure fit for purpose of all e-systems (CSV / CSA) and data governance
  • Lead direct team and matrix teams to execute on critical path process improvements in collaboration with business needs.

• Product & Portfolio Oversight:

• Collaborate with R&D and product management to ensure quality systems products meet market demands and regulatory standards.
• Champion VOC (voice of the customer) to guide development and improvements of quality systems tools and services.

• Regulatory & Compliance Expertise:

• Stay abreast of industry regulations (FDA, EMA, ISO, ICH, etc.) and ensure alignment in product offerings and customer guidance.
• Advise internal and client teams on compliance best practices related to quality systems (e.g., QMS, CAPA, audit readiness).

QUALIFICATIONS

• Bachelor's or Master’s degree in Life Sciences, Engineering, Business, or related field. Advanced degree (MBA, PhD) preferred.
• 10+ years of experience in biotechnology, pharmaceutical, or life sciences industry.
• Expertise in business process management and continuous improvement methodology
• Experience in computerized systems management. Direct expertise using Veeva Vault platform is preferred
• Proven track record in sales leadership, business development, or strategic partnerships.
• Exceptional communication, negotiation, and leadership skills.

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.