Associate Director, R&D Quality Assurance in Cambridge, MA



$150K - $200K*


Quality Management, Life Sciences


11 - 15 years

Job Description

The Associate Director, R&D Quality Assurance (QA) will support the organization by providing GLP/GTP/GCLP QA oversight for research & development (R&D) activities required at all stages of bluebird bio products' life cycle. In this position, the incumbent will be actively involved in executing the R&D QA strategy and 21 CFR Part 58 Quality Assurance Unit (QAU) activities by participating in R&D program teams, contributing to risk-based assessments, providing R&D QA support to foster cross-functional partnerships, and implementing regulatory intelligence processes. This role will be involved in review of MAA/BLA submissions, contribute to inspection readiness efforts and Quality Management System (QMS) activities including procedural development, metrics tracking, and other process improvements. Additionally, the Associate Director, R&D QA will be responsible for ensuring that internal and external audits, deviations, and CAPAs are documented and remediat

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Valid through: 2020-5-19

About Blue Bird Corporation

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