Gene Therapy CMO GMP Auditor – US & EU Regulatory Experience

Gene Therapy CMO GMP Auditor – US & EU Regulatory Experience

Location: Massachusetts
Work Arrangement: Onsite Audit
Start: Q1 2027
Travel: Onsite presence required
Duration: 2–3 day audit

Position Overview

We are seeking an experienced Gene Therapy GMP Auditor to conduct an onsite audit of a contract manufacturing organization (CMO) supporting gene therapy drug substance (DS) and drug product (DP) manufacturing operations.

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

This engagement requires a senior auditor with strong technical knowledge of 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 an onsite GMP audit of a gene therapy CMO.

• Evaluate gene therapy drug substance and drug product manufacturing operations.

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

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

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

• 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 prepare an 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.

Required Qualifications

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

• Strong gene therapy manufacturing experience.

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

• Strong knowledge of both U.S. and EU regulatory and GMP requirements.

• Experience conducting audits of GMP manufacturing facilities and evaluating Quality and manufacturing operations.

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

• Ability and willingness to travel onsite to Massachusetts for the audit.

Ideal Candidate

The ideal consultant is a senior GMP auditor with substantial gene therapy manufacturing expertise and strong knowledge of both U.S. and EU regulatory expectations. They can combine technical understanding of DS and DP operations with rigorous audit skills to independently assess a CMO's compliance posture and clearly document meaningful findings.