Associate Director, Quality Assurance Operations
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Join bluebird bio’s enthusiastic and collaborative Quality Operations team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to manage and oversee a team focusing on quality oversight of external manufacturing. The Quality Operations team focuses on quality release of product manufactured at external contract manufacturing organizations (CMO), including CMO oversight of batch review, resolution of quality systems encountered while manufacturing and testing, and generation of disposition documentation. The Associate Director of Quality Operations will support the organization by ensuring conformance to established quality processes and standards while actively working to continuously improve them. In this position, you will be responsible for developing risk-based quality oversight of CMO and establishing (while actively improving) quality expectations. Additionally, you’ll work closely with other internal CMC teams to build the Quality Operations department as bluebird grows; creating an energized, efficient, and effective team.
About the Role:
- Support bluebird bio Manufacturing Operations and Quality Control during batch production, ensuring unexpected events are handled compliantly and in a timely manner.
- Ensure an appropriate, consistent, and harmonized approach in quality expectations for CMOs, including establishment of Quality Agreements.
- Build sustainable, compliant and collaborative relationships with Quality partners at CMOs
- Manage adherence to scheduled timelines for bluebird bio drug product release/disposition.
- Prepare key performance indicator data via review, analysis and identification of trends of quality system records at CMOs and provide periodic updates to Quality Leadership
- Manage problems of diverse scope using a high degree of judgment and risk-based decision making.
- Review documents associated with deviations, investigations, OOS results, and CAPA action plans.
- Review and approve internal and external documentation, ensuring compliance with applicable cGMP regulations and industry guidelines.
- Review and approve deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check, as required.
- Identify issues and effectively and proactively resolve them in a diplomatic, professional, and constructive manner.
- Engage in activities to continuously assess and improve Lot Review and Disposition processes.
- Support the development, implementation, and revision of corporate quality systems.
- BA/ BS and a minimum of 12+ years in Quality Assurance
- Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and quality leadership
- Experience with managing contract manufacturing and/or testing organizations, including quality agreement negotiation
- Ability to intake and process large quantities of information and subsequently make concise and timely decisions.
- Solid understanding and experience with product lot disposition, investigations, change control, and process qualification and validation
- Ability to communicate above and below level in a way that fosters positive relationship building
- Strong knowledge of GxP regulations, quality systems, and regulatory guidance documents in US (and EU, preferred)
- Demonstrates flexibility and excels within a fast-paced environment with changing priorities.
- Demonstrated project management skills
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
- Lean Six Sigma Green Belt, preferred
- Experience with Sharepoint, Veeva eQMs, Visio, and excel based programs a plus
- Ability to travel approximately 15-25%
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
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.