Director / Sr. Director, Quality Compliance New Somerville, Massachusetts, United States - bluebird bio : Job Details

Somerville, Massachusetts, United States

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
• 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.

We are seeking a Senior Director, Quality Compliance who will lead and oversee the compliance function within the Quality organization, ensuring that all commercial operations—including manufacturing, supply chain, distribution, and post-market activities—adhere to applicable global regulatory requirements and internal standards. Your role will be responsible for building and sustaining a culture of quality, integrity, and compliance across the organization. You bring deep expertise in GxP regulations, a strong background in commercial biotech operations, and the ability to partner cross-functionally to drive operational excellence. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

• Provide compliance support for all programs (commercial and clinical)
• Execute on critical compliance escalations, risks and events (Risk register, BPDR, recalls, complaints)
• Manage Audit program including self-inspection and R&D
• Third party qualification includes external audits, initial qualification and monitoring / requalification on periodic frequency.
• Foundational compliance for bbb including QMS oversight, document control, record retention and training
• Ensure inspection readiness at all times and support partner inspection readiness activities as needed.
• Provide strategic leadership for Quality Compliance across global commercial operations.
• Develop, implement, and maintain the company's quality compliance programs, policies, and procedures in alignment with FDA, EMA, ICH, and other applicable regulatory requirements.
• Serve as a key member of the Quality Leadership Team, influencing strategy, governance, and resource planning.

• Bachelor's degree in life sciences, engineering, or related field required; advanced degree preferred.
• 12+ years of progressive experience in Quality and Compliance within the biopharmaceutical industry, with at least 5 years in a senior leadership role.
• Deep knowledge of GxP regulations (GMP, GDP, GLP, GCP) applicable to commercial biotech operations.
• Proven track record in leading regulatory inspections (FDA, EMA, MHRA, etc.) with successful outcomes.
• Experience building and scaling global quality compliance systems and programs.
• Strong collaboration and influencing skills across diverse functions and levels of the organization.
• Exceptional judgment, integrity, and ability to make risk-based decisions in a fast-paced environment.
• Excellent communication, leadership, and presentation 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.

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