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Senior Manager, Document Control and Training

Posted on Apr 6, 2021 by bluebird bio, Inc.

Cambridge, MA 02138
Research
Immediate Start
Annual Salary
Full-Time


The Quality team at bluebird is all about working collaboratively to ultimately reach our goal of serving patients and their families! The Senior Manager of Document Control and Training is responsible for ensuring that document management and training programs are implemented and effectively administered while maximizing efficiency, complying with industry standards, and achieving compliance targets. You will collaborate with local and global stakeholders, providing leadership for the streamlining/maturation of local business processes to provide an enhanced customer experience. Come fly with us as we progress towards our goal of delivering life changing therapies for patients!


HOW YOU'LL FLY


As a Senior Manager of Document Control and Training bird reporting to Associate Director of Document Management, youll help to bring more patients their bluebird days by:


Managing the training and document management systems, processes, and initiatives while providing and executing innovative ideas to advance process efficiencies and system improvements
Ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
Managing the Doc Control and Training Systems, logistics, delivery, metrics and maintenance while identifying and effectively resolving quality issues/discrepancies
Providing oversight of the team and managing their distribution of work
Managing the Cambridge site's daily document management and training operations, including (but not limited to) ensuring appropriate documents standards are developed and managed, workflows are processed and documents archived appropriately, training requirements for GxP employees are identified and completed, and new hires are effectively onboarded
Globally owning and managing the document management and training business processes and the electronic systems supporting GxP documents and training needs, including (but not limited to) scaling business processes to match recent and future growth, developing and seeing through implementation of strategic plans and collaborating with global stakeholders to ensure that current and future processes and systems meet all user requirements


WHAT YOU'LL BRING


You're the bird we're looking for if you have:


BA/BS, preferably in a scientific discipline with 7+ years of document control and training experience, 5+ of which are in a GxP-regulated industry; 5+ years of management experience
Experience leading and owning a GxP training program, leading investigations into deviations with CAPA responsibility
Extensive experience managing Document Control Systems
Learning Management System (LMS) ownership, implementation, facilitation experience
Demonstrated excellent facilitation, presentation, instructor skills
Veeva Quality Vault and ComplianceWire experience strongly preferred




Reference: 1152693992

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