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Senior Manager, QC Electronic Systems

Posted on Apr 13, 2021 by bluebird bio, Inc.

Durham, NC 27701
Research
Immediate Start
Annual Salary
Full-Time


Join bluebird bios 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




Reference: 1162847700

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