Senior Compliance Auditor - Cambridge, United States - EPM Scientific

Description

Senior Compliance Auditor

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

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.