Gene Therapy CMO GMP Auditor - US & EU Regulatory Experience

Job Description

Job Description

Gene Therapy CMO GMP Auditor – US & EU Regulatory Experience

Locations: Columbus, Ohio & Plainville, Massachusetts
Work Arrangement: Onsite Audits
Travel: Onsite presence required
Modality: AAV Gene Therapy
Development Stage: Clinical Supply – Phase 1/Pivotal
Engagement Model: Co-Auditor

Audit Schedule

Columbus, Ohio

• December 16–17, 2026

• 2-day onsite audit

Plainville, Massachusetts

• Targeting late March 2027

• 2-day onsite audit

The client would prefer to utilize the same auditor for both audits, if possible .

Position Overview

We are seeking an experienced Gene Therapy GMP Auditor to support two onsite audits of contract manufacturing organizations (CMOs) involved in AAV gene therapy manufacturing for clinical supply supporting Phase 1/pivotal development .

The consultant will evaluate manufacturing and Quality operations against applicable GMP expectations, with particular emphasis on AAV gene therapy manufacturing and both U.S. and European Union regulatory requirements .

The audit scope will be comprehensive and will include drug substance (DS), drug product (DP), QC laboratory operations, warehouses, utilities, Quality Systems, and supporting manufacturing operations . The assessment will include applicable requirements under 21 CFR Parts 210/211 and EudraLex Volume 4, including Annex 1 .

The selected consultant will work as a co-auditor for both audits. The client would ideally like to engage the same auditor for the Columbus, Ohio and Plainville, Massachusetts audits.

This engagement requires a senior auditor with strong technical knowledge of AAV gene therapy manufacturing who can effectively assess DS and DP operations, evaluate objective evidence, identify meaningful compliance risks, and clearly document audit findings.

Key Responsibilities

• Prepare for and conduct onsite GMP audits of gene therapy CMOs.

• Serve as a co-auditor alongside the client's designated auditor.

• Evaluate AAV gene therapy drug substance and drug product manufacturing operations supporting clinical supply.

• Conduct a comprehensive assessment encompassing DS, DP, QC laboratories, warehouses, utilities, Quality Systems, and associated manufacturing operations.

• Assess site operations against applicable U.S. and EU GMP requirements and regulatory expectations , including:

  • 21 CFR Parts 210/211

  • EudraLex Volume 4

  • EU GMP Annex 1

• Review Quality Systems, manufacturing practices, documentation, controls, facilities, and supporting records within the audit scope.

• Apply AAV/gene therapy manufacturing expertise to identify product-, process-, and facility-specific compliance risks.

• Evaluate applicable contamination-control and aseptic-processing practices where relevant to operations.

• Interview relevant site personnel and evaluate supporting records and objective evidence.

• Identify and clearly communicate significant observations, compliance gaps, and areas requiring further attention.

• Document audit findings and contribute to preparation of the audit report summarizing observations and conclusions.

• Coordinate with the sponsoring organization's technical and Quality representatives regarding audit scope, areas of emphasis, and relevant operational considerations.

• Support both the Columbus, Ohio and Plainville, Massachusetts audits, if availability permits.

Required Qualifications

• Significant GMP auditing experience within the pharmaceutical or biotechnology industry.

• Strong hands-on knowledge of AAV gene therapy manufacturing.

• Demonstrated knowledge of gene therapy drug substance and drug product manufacturing operations .

• Experience auditing manufacturing operations supporting clinical-stage gene therapy programs .

• Strong knowledge of both U.S. and EU GMP requirements , including 21 CFR Parts 210/211 and EudraLex Volume 4.

• Strong working knowledge of EU GMP Annex 1 and its application to relevant manufacturing operations.

• Experience conducting comprehensive GMP audits covering areas such as manufacturing, QC laboratories, warehouses, utilities, facilities, and Quality Systems.

• Ability to assess technical and Quality documentation, interview site personnel, evaluate objective evidence, and identify meaningful compliance risks.

• Strong written and verbal communication skills with the ability to clearly document and communicate audit observations.

• Ability and willingness to travel onsite for the scheduled audits.

Preferred Availability

Preference will be given to consultants who can support both audits :

• Columbus, Ohio: December 16–17, 2026

• Plainville, Massachusetts: Late March 2027

The client would like to utilize the same auditor for both engagements whenever possible.

Ideal Candidate

The ideal consultant is a senior GMP auditor with substantial AAV gene therapy manufacturing expertise and strong knowledge of both U.S. and EU regulatory expectations. They have direct experience evaluating gene therapy DS and DP manufacturing operations and are comfortable auditing an all-inclusive scope covering manufacturing, laboratories, warehouses, utilities, facilities, and Quality Systems.

They understand the regulatory expectations applicable to clinical-stage AAV manufacturing, including 21 CFR Parts 210/211, EudraLex Volume 4, and EU GMP Annex 1 , and can combine technical gene therapy expertise with rigorous audit skills.

The consultant should be comfortable working as a co-auditor and, ideally, be available to support both the December 2026 Columbus audit and the March 2027 Plainville audit.