Quality Systems Senior Specialist/Lead Specialist at bluebird bio, Inc. in Durham, North Carolina

Job Description:

ABOUT THE NEST

At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 1100+ doers, thinkers and collaborators across 7 countries with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our flock and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.

HOW YOU'LL FLY

* Manage Quality Systems to support clinical and commercial manufacturing operations.
* Provide subject matter expertise to assure deviation, CAPA, and change control systems meets regulatory requirements and industry practices.
* Responsible for training site personnel in the deviation, CAPA, and change control processes.
* Manage the site's Quality Risk Management program.
* Facilitate Quality Risk Assessments as needed.
* Compile and evaluate quality metrics for dissemination at Quality Council and Management Review.
* Review, revise, and approve GxP controlled documents to ensure compliance and facilitate continuous improvement.
* Assist with internal and/or external audit and inspection readiness activities.
* Contribute to the development of a robust inspection readiness program.
* Develop and maintain site master file.
* Manage projects as assigned.\\"

WHAT YOU'LL BRING

* BA/BS in a scientific discipline and a minimum of 5 - 8 years of experience in a Quality Assurance/Quality Systems role.
* Experience with managing deviation, CAPA, and change control processes.
* Strong knowledge in the development of a robust QMS.
* Experience supporting regulatory inspections and systems audits.
* Knowledge of US and EU cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements.
* Experience with supporting commercial manufacturing of sterile products.
* Skills to lead cross-functional teams to effectively resolve quality issues.
* Excellent communication skills and ability to influence across multiple functions.
* Ability to travel approximately 10%.
* Experience with facilitating quality risk assessments (FMEA, PHA, etc.) desired.
* Effectively partnering with internal and external organizations.
* Project management experience desired.
* LEAN/Six-Sigma experience desired.
* Ability to identify and implement improvement opportunities (including change management)
* Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision.
* Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.

All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.

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..