Senior Specialist, Quality Operations (Contract)

Location
Cambridge, MA, United States
Posted
Aug 24, 2018
Ref
1288823
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Contract
Quality Operations, Senior Specialist

12 month Contract

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 Operations team to contribute to the overall success of our novel gene therapy approach. A Quality bird's #1 responsibility is to ensure we're developing high quality products to treat our patients. We work hard every day to foster and drive a culture of true-blue Quality through every facet of our company and every phase of our development. Make your mark with us as we strive to blaze new trails with our gene therapy technology!

We seek an experienced Quality professional to overseeing batch review, resolution of quality systems encountered while manufacturing and testing, and generation of disposition documentation. The Quality Operations Senior Specialist 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 systems encountered while manufacturing and testing, and generation of disposition documentation. Additionally you'll work closely with the Quality Operations Management team to build the Operations department as bluebird grows; creating an energized, efficient, and effective team.

About the position:
  • Support bluebird bio Manufacturing Operations during batch production, ensuring unexpected events are handled compliantly.
  • Manage release testing for bluebird bio starting materials.
  • Management of data review, analysis, identification of trends, and complex problem solving.
  • Ensure an appropriate, consistent, and harmonized 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 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 generation at CMOs and CTOs, providing period 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, providing periodic updates to Management - 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, flexible, 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 3-5 years in Quality Assurance / Quality Control
  • Knowledge of cell culture and upstream manufacturing
  • Knowledge of working and master cell banks and industry guidance
  • Demonstrated leadership within teams producing results
  • Ability to demonstrate project management skills
  • Experience with disposition, investigations, change control, and process qualification and validation
  • Ability to communicate above and below level in a way that fosters relationship building
  • Strong knowledge of GxP regulations, quality systems, and guidance documents
  • Experience with managing contract manufacturing and contract testing organizations beneficial
  • Excellent organizational and project management skills, sufficient to multi-task in an extremely 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 priorities with aggressive timelines
  • Ability to travel approximately 15-25%
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself