Senior Manager, Quality Assurance

Location
Cambridge, MA, United States
Posted
Nov 07, 2018
Ref
1420350
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Join our growing Quality group

bluebird bio is developing potentially transformative, one-time gene therapies for severe genetic and orphan diseases. At the heart of bluebird bio's product creation efforts is its broadly applicable gene therapy platform for the development of new treatments for diseases with few or no clinical options. bluebird bio has two clinical stage product candidates in development, one for childhood cerebral Adrenoleukodystrophy (CCALD) and one for beta-thalassemia major/sickle cell disease, and an early stage oncology program in partnership with Celgene Corporation.

Join bluebird bio's enthusiastic and collaborative Quality Assurance team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to manage and oversee a team focusing on supplier quality management, batch review, resolution of quality events encountered while manufacturing and testing, and generation of disposition documentation. The Senior Manager of Quality Assurance will support the organization by ensuring conformance to established quality processes and standards while actively working to continuously improve them. In this position, you will be responsible for overseeing batch review, manage all activities associated with release testing, resolution of quality events encountered while manufacturing and testing, and generation of disposition documentation. Additionally, you'll work closely with other Quality Management teams to build the Quality Assurance department as bluebird grows; creating an energized, efficient, and effective team.

About the position:
  • Support bluebird bio Manufacturing and Testing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner.
  • Manage release testing and adherence to scheduled timelines for bluebird bio Drug Product lots.
  • Management of data review, analysis, identification of trends, and complex problem solving.
  • Manage problems of diverse scope using a high degree of judgment and risk-based decision making.
  • Ensure an appropriate, consistent, and harmonized quality approach is standard across all CMOs and CTOs.
  • Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports;
  • Prepare and/or review documents associated with deviations, investigations, OOS results, and CAPA action plans.
  • Ensure all documentation complies with cGMP regulations and industry guidelines.
  • Build on relationships with our Quality partners at CMOs and CTOs ensuring quality issues are tracked and resolved in a timely manner.
  • Track and trend quality system performance at CxOs providing periodic updates to Management - Review and approve deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required.
  • Track and trend batch execution at CMOs and release testing at CMOs, providing periodic updates and Quarterly Metrics data to Management, with alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch.
  • Identify quality issues and effectively and proactively resolve them in a diplomatic, professional, and constructive manner.
  • Engage in activities to continuously assess and improve Lot Review and Disposition processes.
  • Support the development, implementation, and revision of corporate quality systems.

About you:
  • BA/ BS and a minimum of 10+ years in Quality Assurance
  • Demonstrated leadership within teams producing results
  • Ability to demonstrate project management skills
  • Ability to receive and process large quantities of information, to make concise and timely decisions
  • Experience with product lot disposition, investigations, change control, and process qualification and validation
  • Ability to communicate above and below level in a way that fosters positive relationship building
  • Strong knowledge of GxP regulations, quality systems, and guidance documents
  • Experience with managing contract manufacturing and contract testing organizations would be beneficial in this role.
  • Demonstrates flexibility and excels within a fast-paced environment with changing priorities.
  • Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
  • Lean Six Sigma Green Belt - preferable but not required
  • Experience with Sharepoint, Veeva eQMs, Visio, and excel based programs a plus
  • Ability to travel approximately 15-25%
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself