ABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
We seek an experienced Quality professional to overseeing batch review, resolution of quality systems encountered during external manufacturing and testing of bluebird bio products. In this position you will be responsible for quality oversight of batch review, in process and release testing, resolution of quality systems encountered while manufacturing and testing, and generation of disposition documentation. In addition, there will be external manufacturing vendor relationship and communication needed to support efficient and compliant processes.
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:
- Supporting bluebird bio External Manufacturing Operations and Quality Control Integrated Operations during batch production and testing, ensuring unexpected events are handled compliantly.
- Reviewing and approving documents including: Manufacturing and testing batch records in support of product release
- Preparing and reviewing quality system documentation associated with deviations, investigations, OOS results, and CAPA action plans.
- Identifying quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
- Tracking and trending quality system generation at CMOs and CTOs
- Tracking and trending batch execution at CMOs.
- Supporting the development, implementation, and revision of corporate quality systems.
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- BA/ BS and 8+ years in Quality Assurance, including experience with external manufacturing quality oversight
- Experience and/or knowledge of cellular therapy collection, processing and upstream manufacturing beneficial, but not required
- Experience with disposition, deviation investigations, change control, and process improvements
- Ability to communicate above and below level in a way that fosters relationship building, including external relationships with vendors
- Strong knowledge of GxP regulations, quality systems, and guidance documents
- Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
This role is a 12-month contract position
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
