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.
