Uncubed
   

Sr Manager, QC Electronic Systems

Bluebird Bio, Durham, North Carolina, United States

integrated product platforms with broad therapeutic potential


On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.

 

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 the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams 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.

ABOUT THE NEST

Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek and experienced Sr Manager, at our Durham, NC facility, to provide technical oversight and governance of QC lab automation and computerized systems. This includes leading software configuration projects, establishment and maintenance of user accounts, configuration of user roles and privileges, monitoring installation of software and patches, and other related activities. In addition, this role will be tasked with implementation of a LIMS system across bluebird bio QC laboratories. This role will partner heavily with bluebird QC and IT functions to ensure QC electronic systems are in compliance with all applicable regulations and bluebird policies

HOW YOU’LL FLY


Ensure QC electronic systems comply with applicable regulations and procedures
Provide leadership in the implementation of a LIMS system across bluebird bio sites
Monitor system configuration and use account privileges to ensure data integrity
Partner with IT to assess system patches and updates prior to implementation to ensure they do not conflict
with QC computerized systems
Provide day to day end user support for QC systems
Represent QC on cross functional IT infrastructure projects to ensure QC electronic systems remain compliant
Lead and support continuous improvement initiatives and CAPAs related to QC electronic and lab automation
systems
Serve as SME for all QC electronic systems, including interfacing with regulatory agencies during inspections
Provides customer support and training, troubleshoot problems, manage change controls, and perform system
maintenance, as needed


WHAT YOU’LL BRING

Requires BS/BA in a relevant field

Knowledge of 21 CFR Part 11, Annex 11 Regulations and GMPs required
Experience with LIMS implementation in a GMP environment required
Minimum 8 years of relevant experience in a similar role
Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
Superb organizational, analytical, and communication skills and a ""do what it takes"" attitude
A passion for addressing the critical unmet medical needs of patients
Self-directed individual who is able to work with limited direction in a fast-paced, goal oriented environment
Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself"

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.

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.