Lead Specialist, Quality Operations
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
Join our growing Quality group. bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio’s product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options.
Join bluebird bio’s enthusiastic and collaborative Quality Assurance team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to provide Quality Operations Support for Quality Control. The Quality Operations, “QA for QC” Team oversees resolution of quality systems encountered on in-process and lot release testing, and stability testing performed both in our internal GMP QC Testing Laboratory, and at our CTO’s, as well as supports the Stability, QSAT and Critical Reagents teams with protocol and report generation.
In addition, there will be external vendor relationship and communication needed to support efficient and compliant processes and program management.
About the position:
- Support bluebird bio External Manufacturing Operations and Quality Control Integrated Operations during batch production and testing, ensuring unexpected events are handled compliantly.
- Management of data review, analysis, identification of trends, and complex problem solving.
- Review and approve documents including testing batch records, stability and qualification protocols and reports, lab investigations, retest plans, deviations, expiration extensions and supporting trend analyses, and change controls.
- May be called on to assist in manufacturing batch record review and review of internal documentation and forms in support of product lot release.
- Prepare and review quality system documentation associated with deviations, investigations, OOS results, and CAPA action plans.
- Ensure all documentation complies with cGMP regulations and industry guidelines.
- Track and trend quality system generation internally and at CTOs.
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
- Engage in activities to continuously assess and improve Quality processes.
- Support the development, implementation, and revision of corporate quality systems.
- BA/ BS and a minimum of 8 years in Quality Assurance and/or Quality Control, including experience with external CxO quality oversight. Previous QC Lab experience and/or support highly desired
- Experience and/or knowledge of cellular therapy collection, processing and upstream manufacturing beneficial, but not required
- Experience and/or knowledge of QC biopharmaceutical testing, cell-based assays, stability program management are all plusses.
- Ability to demonstrate project management skills
- Experience with deviation investigations, OOS lab investigations, change control, CAPA development and process improvements
- Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
- Strong knowledge of GxP regulations, quality systems, and guidance documents (including ICH)
- Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities and multiple stakeholders
- Experience interacting with contract testing organizations, including identifying, communicating and resolving complex issues
- Experience with impact and risk assessment tools, process mapping and process improvement tools
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
- 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.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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