Quality Assurance: Manager, Document and Training Management

Location
Durham, NC, United States
Posted
Oct 05, 2018
Ref
1224216
Required Education
Bachelors Degree
Position Type
Full time
The Manager, Document and Training Management is responsible for ensuring that the document and training programs are developed, implemented and effectively administered consistently, in a manner that maximizes efficiency, complies with industry standards, and achieves desired compliance targets. Collaborate in conjunction with our headquarters nest (Cambridge) for the development and implementation of both document and training programs at the Durham manufacturing facility. Thoroughly identify educational and document management needs, articulate goals for meeting these needs, and identify creative, high impact and sustainable approaches for meeting these goals. Provide leadership and management of the document and training program to ensure that the appropriate activities are developed and implemented in line with strategic objectives. This is a great opportunity to have a major impact on developing the quality function and quality culture at bluebird bio.

About the role:
  • Implement a site-specific document management process from document generation through archival at the bluebird facility in Durham, NC that is aligned with company policies and procedures which includes document issuance and reconciliation.
  • Support of regulatory inspections including managing the document room and assisting where needed throughout a company or regulatory inspection.
  • Manage problems of diverse scope using a high degree of personal judgment, and must be able to effectively represent bluebird bio Quality to local, corporate, and regulatory agencies
  • Develop, manage and communicate bluebird bio's training and document management requirements and initiatives.
  • Partner with internal/external groups, colleges/universities, and vendors to identify/implement innovative solutions that help advance the efficiency, productivity, and technical depth of the quality and bluebird team.
  • Provide and execute innovative ideas to advance document process efficiencies, training effectiveness, and share best practices.
  • Responsibilities include oversight of program design, Learning Management System, Document Management System, logistics, delivery, metrics and maintenance
  • Review and approve both procedural and technical documents.
  • Ensure that document management and training programs are appropriately reviewed, technically sound, and aligned with goals and bluebird philosophy
  • Foster a quality mind-set within the Document/Training team as well as across Quality and throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions.
  • Establish a training program at the Durham facility that utilizes specific role-based qualification training.
  • Review and approve both procedural and technical documents.
  • Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

About You:
  • BA/BS and/or Masters degree, and technical understanding of biopharmaceutical production.
  • A minimum of ten (10) years of experience in the industry, ideally early clinical phases through commercial drug product.
  • Experience with FDA inspections and inspection readiness activities including leading specific inspection activities. (i.e. document room)
  • Strategic experience with senior leadership team level clients, strong decision making capability.
  • Strong knowledge GxP regulations, quality systems (Document Control, Training/Qualification, Change Control, Computer System Validation, 21CFRPart11) and guidance documents
  • Strong leadership and management experience with ability to work in a matrix environment.
  • Must have excellent attention to detail, project and time management skills as well as the ability to manage multiple priorities with aggressive timelines
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Ability to travel up to10% domestically.
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

Success Factors:
  • Ability to motivate and lead.
  • Effective cross-functional partnering.
  • Risk management experience a bonus
  • Project management experience.
  • Experience with regulatory inspections and audits.
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation 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.
  • Admin experience with Veeva Quality Docs or ComplianceWire a plus
  • LEAN/Six-Sigma training (preferred)
  • Risk management experience a bonus


This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular. bluebird bio is a publicly traded company on the NASDAQ Global Select Market and trades under the symbol BLUE. We were named to the 2012 FierceBiotech Fierce 15. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.