Senior Director, Quality Assurance
Bluebird Bio, Cambridge, MA, USA
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative Quality Assurance team to contribute to the overall success of our novel gene therapy. As a key member of bluebird’s Quality team, the Sr. Director, Quality Assurance will be responsible for leading all corporate Quality Assurance strategies ensuring compliance with global GxP regulations. This position will lead Quality Compliance (audits and inspection readiness), Quality Operations (batch disposition), Quality Systems (deviation, CAPA, change control, document control and training) and Quality Assurance Validation.
bluebird bio’s Quality Assurance collaborates with internal and external partners to implement a culture of quality to ensure the safety of patients. Navigating ambiguity using risk-based logic to ensure appropriate flexibility without compromising compliance is key to the success of bluebird bio’s Quality Assurance Team. A strong vision of Quality and the ability to navigate complex issues without rigidity is a must for this position.
The Sr. Director, Quality Assurance will manage day to day operations including, goal setting, budgeting, hiring and development of a team. This position will be a member of the Quality Leadership Team and will report to the V.P. of Quality.
About the role:
- A Leadership role expected to embrace bluebird bio’s Core Values; b colorful, b cooperative, and b yourself (bluebirdbio.com)
- Represent Quality with a strong voice
- Collaborate and interact with various departments and levels of management to accomplish company objectives
- Deep knowledge of all facets of Quality Assurance; GCP, GMP, GLP, GTP
- Lead and continue to improve the Quality Management System (QMS) of bluebird bio
- Drive continuous improvement within Quality and throughout bluebird bio
- Lead the Quality Council driving a culture of quality throughout bluebird bio
- Collaborate cross-functionally, develop strong relationships with partners both internally and externally
- Provide performance reviews, development plans and set goals for department staff in alignment with company goals
- Develop and manage the annual budget for Quality Assurance
- A strategic thinker that can break down barriers, drive great decisions, and make an impact
- Experienced building teams, for both today and tomorrow, through an investment coaching and development
- Nimble and resilient to the fast changing gene-therapy environment
- Inspiring and credible communicator
- Collaborative with partners to advance the bluebird bio mission
- A resilient and visionary Quality Leader willing to pave a path
- Experience leader in Quality Assurance, Quality Systems and/or Quality Operations
- Strong knowledge of global regulations (EU, U.S., Japan)
- Bachelor of Science degree in a scientific discipline is required
- A minimum of 15 years of experience in the industry, ideally all clinical phases through commercial drug product
- Ability to Travel (20%)
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.