Gene Therapy GMP Auditor – US and EU Regulatory Experience

Job overview

The Gene Therapy GMP Auditor – US and EU Regulatory Experience role involves onsite audits in Columbus, OH, and Plainville, MA. Compensation is not specified. The auditor supports two audits of contract manufacturing organizations producing AAV gene therapy clinical supply for Phase 1/pivotal development.

What you'll do

• Prepare for and conduct onsite GMP audits as a co-auditor
• assess AAV gene therapy drug substance and drug product manufacturing, QC laboratories, warehouses, utilities, Quality Systems, and supporting operations
• evaluate compliance with 21 CFR Parts 210/211, EudraLex Volume 4, and EU GMP Annex 1
• review records and interview site personnel
• identify and communicate compliance risks and observations
• document findings and contribute to the audit report
• coordinate with the sponsoring organization’s technical and Quality representatives. Support for both audits is preferred, if availability permits.

What we're looking for

Skills & competencies

gene therapy gmp auditor

columbus oh

plainville ma

aav gene therapy

gmp auditing

co-auditor

drug substance

drug product

clinical supply

us and eu gmp

21 cfr parts 210/211

eudralex volume 4

eu gmp annex 1

onsite audits

Work arrangement

• Weekend coverage required

Why this role

The scheduled audits are December 16–17, 2026, in Columbus, OH, and a targeted two-day audit in late March 2027 in Plainville, MA. Requires significant pharmaceutical or biotechnology GMP auditing experience and hands-on AAV gene therapy manufacturing knowledge.

About the employer

The FDA Group is hiring for this role. Industry: Process, Physical Distribution, and Logistics Consulting Services. Sector: 54.