bluebird bio

About the Company

bluebird bio is pursuing curative gene therapies to give patients and their families more bluebird days. With a dedicated focus on severe genetic diseases, bluebird has industry-leading programs for sickle cell disease, b-thalassemia and cerebral adrenoleukodystrophy and is advancing research to apply new technologies to these and other diseases. We custom design each of our therapies to address the underlying cause of disease and have developed in-depth and effective analytical methods to understand the safety of our lentiviral vector technologies and drive the field of gene therapy forward. Founded in 2010, bluebird has the largest and deepest ex-vivo gene therapy data set in the world--setting the standard for the industry. Today, bluebird continues to forge new paths, combining our real-world experience with a deep commitment to patient communities and a people-centric culture that attracts and grows a diverse flock of dedicated birds. Community guidelines: http://bit.ly/bbbGuidelines

Listed Jobs

Company Name

bluebird bio

Job Title

Director / Sr. Director, Quality Compliance

Job Description

Job Title: Director / Sr. Director, Quality Compliance Role Summary: Lead and oversee the global Quality Compliance function across all commercial operations, ensuring adherence to GxP, FDA, EMA, ICH, and other regulatory requirements while fostering a culture of quality and integrity. Expectations: Deliver a risk‑based, compliant environment for manufacturing, supply chain, distribution, and post‑market activities; lead audit readiness, third‑party qualification, and continuous improvement initiatives; partner cross‑functionally to shape strategy and resource planning. Key Responsibilities - Provide compliance support for commercial and clinical programs. - Execute and resolve critical compliance escalations, risks, and events (risk register, BPDR, recalls, complaints). - Manage the audit program, including self‑inspections, R&D audits, and external partner inspections. - Lead third‑party qualification processes, including initial qualification, monitoring, and requalification. - Oversee foundational compliance functions: QMS, document control, record retention, and training. - Maintain inspection readiness and support partner inspection readiness activities. - Develop, implement, and sustain quality compliance programs, policies, and procedures aligned with regulatory requirements. - Serve on the Quality Leadership Team to influence strategy, governance, and resource planning. Required Skills - Deep knowledge of GxP (GMP, GDP, GLP, GCP) for commercial biotech operations. - Proven track record managing FDA, EMA, MHRA, and other regulatory inspections with successful outcomes. - Experience building and scaling global quality compliance systems and programs. - Strong collaboration, influencing, and communication skills across diverse functions. - Risk‑based decision making and exceptional judgment in fast‑paced environments. - Leadership, presentation, and stakeholder management abilities. Required Education & Certifications - Bachelor’s degree in life sciences, engineering, or related field (required). - Advanced degree (master’s or PhD) preferred. - No specific certifications listed; relevant GxP and regulatory compliance experience required.

Somerville, United states

Hybrid

Senior

21-09-2025

Company Name

bluebird bio

Job Title

Manager, Project Coordinator

Job Description

Job Title: Project Coordinator Manager Role Summary: Supports cross-functional teams in administrative, procurement, and contract processing operations. Ensures alignment of timelines, deliverables, and stakeholder communication while maintaining compliance and process efficiency. Expectations: Demonstrates 5+ years of administrative/project coordination experience in biotechnology, pharmaceutical, or clinical research industries. Proficient in multitasking complex administrative workflows and fostering collaboration across departments. Key Responsibilities: - Manage executive administrative tasks (calendar/scheduling, travel coordination, expense reporting, document preparation). - Coordinate cross-departmental meetings, project tracking, and shared resource maintenance for Technical Operations, Finance, and HR. - Oversight of end-to-end procurement (vendor setup, purchase orders, invoicing) and contract lifecycle management (tracking, renewals, document compliance). - Streamline operational processes (scheduling, expenses, procurement) and maintain SOPs for administrative systems. - Liaise between stakeholders to ensure timely execution of projects and alignment of departmental priorities. Required Skills: Strong organizational and communication skills; expertise in Microsoft Windows tools (Excel, Teams, SharePoint). Ability to prioritize in fast-paced environments. Collaborative mindset with attention to compliance and procedural accuracy. Required Education & Certifications: Bachelor’s degree; 5+ years in biotech, pharmaceutical, or clinical research settings preferred (not explicitly required).

Somerville, United states

On site

Mid level

23-10-2025