Manager, Quality Compliance in Cambridge, MA



$100K - $150K*


Quality Management


8 - 10 years

Job Description

Join bluebird bios Quality Compliance team to contribute to the overall success of our novel gene therapy. As part of bluebird bios Quality team, the Manager, Quality Compliance will support the GCP/GLP/GVP Audit programs to meet all US, European and global Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacovigilance (GVP) requirements.

The Quality Compliance team supports regulatory agency inspections and partner audits, assists with responses to inspection findings, maintains the Approved Vendor List (AVL), supports inspection readiness efforts across bluebird bio operations, manages the Auditor Qualification Program and is responsible for the GxP Audit Program.

About the role:

  • Schedule, execute, report and follow-up on internal and external GCP/GLP/GVP audits (Qualification, Routine, For-Cause)
  • Ensure audit observations are communicated, escalated as required, tracked and remediated in compliance with inte
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Valid through: 2020-5-19

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