ElevateBio

Director, Quality Systems & Compliance

ElevateBio(21 days ago)

Waltham, MA, United States, MassachusettsOnsiteFull TimeDirector$220,000 - $250,000Quality
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About this role

ElevateBio is seeking a Director of Quality Systems and Compliance to provide strategic leadership over the company’s quality systems and compliance programs supporting cell and gene therapy development from early clinical stages through commercial operations. The role oversees the Quality Management System to ensure alignment with global regulatory expectations and industry best practices. This position leads the quality systems/compliance organization and serves as a key partner to cross-functional stakeholders to drive quality governance and organizational alignment.

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Required Skills

  • Quality Systems
  • Quality Compliance
  • QMS
  • GxP
  • CAPA
  • Change Control
  • Deviations
  • Risk Management
  • Supplier Quality
  • Audit Management

+10 more

ElevateBio

About ElevateBio

elevate.bio

ElevateBio is a life sciences company that accelerates the creation of cell and gene therapies by combining integrated technology platforms with development and manufacturing capabilities. It partners with biotech and research teams to provide end-to-end support — from technology development and process optimization to clinical- and commercial-scale manufacturing — aimed at speeding programs to clinic and market. Customers choose ElevateBio for its integrated approach, manufacturing footprint, and expertise in translating genetic medicine programs at scale.

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