Director / Sr Director Quality Assurance (GxP) - Needham, MA

Only for registered members Needham, MA , United States

1 month ago

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Job summary

We value diversity, collaboration and bold thinking in a supportive mission-driven environment.

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Responsibilities

  • Manage the end-to-end lifecycle of GxP systems across QA Clinical Ops CMC and Research ensuring full compliance with 21 CFR Part 11 and modern industry standards
  • Lead qualification risk assessment and ongoing oversight of a diverse ecosystem of internal and external vendors—ranging from eQMS EDMS to training systems supply chain tools and cloud-based clinical applications
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Qualifications
  • Bachelor's degree in Life Sciences or related technical field.

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