Join bluebird bio and take our Quality organization to the next level!
This role will be at the helm to further build and lead all Quality functions for the company in support of our ambitious goals of providing transformative gene therapy products to patients globally. In this role, you will lead Quality Assurance for all GxP functions including internal and external manufacturing and testing, as well as R&D/Clinical, Quality Control, and Quality Systems for all of bluebird including teams in corporate headquarters in Cambridge, manufacturing facility in North Carolina and in our first launch region based in Zug, Switzerland.
The Sr. VP, Quality will manage and continue to grow a talented team of 100+ to oversee all quality-related operations as well as goal setting, budgeting, hiring and development of all Quality teams globally. Own and drive the complete Quality function at a fast-paced and fast-growing biotechnology company with broad application of multiple novel technologies
You will be a member of the Pharmaceutical Science & Quality Leadership Team and will report to the Chief Technology and Manufacturing Officer with a dotted reporting line to the CEO.
About the role:
- Collaborate and interact with broad range of departments and levels of management to accomplish company objectives
- Ability to manage and prioritize multiple projects and demonstrate a leadership style that can marshal the organization’s most important resources to the right outcome
- Continue to build and scale the global Quality organization
- Drive and cultivate a culture of Quality throughout bluebird bio
- Collaborate cross-functionally, develop strong relationships with partners both internally and externally
- Set ambitious goals within Quality and in alignment with company goals
- Propose, review and share ownership of Pharmaceutical Sciences and Quality overall goals
- Develop and manage the annual budgets for all Quality functions
- Regularly report to the bluebird leadership team and the BOD on the state of quality
- Demonstrated skills and track record of building, scaling or integrating operational capabilities on a global basis in the pharmaceutical or biotechnology industry
- Deep knowledge of all facets of Quality Assurance (GCP, GMP, GLP, GTP), Quality Control, and Quality Systems
- A strategic thinker that can break down barriers, drive and make great decisions, and make an impact with a Quality organization
- Demonstrated ability to exercise judgment with the best interests of patients at the forefront
- Nimble and resilient to the fast-changing gene-therapy environment
- Ability to effectively communicate with inspiration, lead and influence individuals from multiple functional departments at all levels of the organization
- Strong organizational and time management skills to balance working on multiple projects and initiatives in parallel at a nimble, fast-paced and innovative company
- Strong knowledge of global regulations (EU, U.S., Japan)
- Excellent people leader with strong mentorship skills. Track record of strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment.
- 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%)
- Be ready to embrace bluebird bio’s Core Values; b colorful, b cooperative, and b yourself (bluebirdbio.com)