Senior Manager/Associate Director QA

2 months ago


Burlington, United States EPM Scientific Full time

Overview:

QA Leader to support the quality management systems and processes for a CRO based in Burlington. Working within pharma in both biologic development and cell and gene therapy and reporting directly to the Senior Director of Global Compliance.

Role Responsibilities:

  • Shape and expand our US quality management systems.
  • Lead audits, ensuring GCP/GLP compliance.
  • Oversee systems, suppliers, and employee training.
  • Drive continuous improvement in quality processes.
  • Champion a strong quality culture within the team.
  • Collaborate with clients, auditors, and internal teams.

Previous Experience:

  • 5+ years QA GCP/GLP experience (biopharma/cell & gene therapy a plus)
  • Passion for quality and cultural change leadership
  • Solid regulatory audit experience (FDA a plus)
  • Excellent communication, teamwork, and leadership skills
  • Experience leading/participating in regulatory GCP/GLP audits



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