Senior Compliance Auditor

3 weeks ago


Cambridge, United States EPM Scientific Full time

Senior Compliance Auditor


Role Description:

  • Oversee and participate in audits, reporting on findings.
  • Manage Quality Technical Agreements with critical suppliers.
  • Conduct internal audits to meet GMPs, 820 standards, and company requirements.
  • Lead and support supplier audits (onsite and remote) for GMP and regulatory compliance.
  • Uphold the Supplier Management Program, including drafting and maintaining Quality Technical Agreements.
  • Address and escalate compliance issues to the appropriate teams.
  • Support the Supplier Management Team and medical device supplier project teams.
  • Develop and revise Standard Operating Procedures (SOPs).


Role Requirements:

  • Bachelor's degree or equivalent with 10 years of experience in a pharmaceutical/biotech quality unit.
  • 5+ years of experience as a qualified auditor, assessing supplier compliance with cGMP, QSR, and ICH regulations.
  • Strong understanding of relevant FDA regulations/guidance and ICH Guidelines.
  • Proven ability to independently plan, execute, and report audits.
  • Experience in cell manufacturing/biologics, medical devices, and/or software quality is a plus.
  • Familiarity with Good Clinical Practice (GCP) and ICH E6 is preferred.


This role is hybrid (Mon, Tue, Thu onsite) with 30% travel within Massachusetts and Michigan.



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