Manager, QC Electronic Systems / LIMS

Location
Durham, NC, United States
Posted
Nov 05, 2018
Ref
1224197
Required Education
Bachelors Degree
Position Type
Full time
Join bluebird bio's enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We seek an experienced 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 systems 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.

About the Role:
  • Ensures QC electronic systems comply with applicable regulations and procedures
  • Provide leadership in the implementation of a LIMS systems 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


About You:
  • 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 communications skills and "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