Gene Therapy CMO GMP Auditor - US & EU Regulatory Experience

Job Description Job Description

GMP CDMO Auditor - AAV Gene Therapy / FDA & EU GMP / Pivotal Readiness

Location: Columbus, OH and Massachusetts

Work Arrangement: Onsite CDMO Audits

Duration: Approximately 96 total consulting hours across two audits (48 hours per audit), plus travel time

Openings: 1 Consultant Preferred for Both Audits

Start: December 16-17, 2026 (First Audit); Late March 2027 (Second Audit)

Schedule: Two onsite audit days per facility, plus preparation and reporting

Travel: Required for both audits; travel expenses covered

Position Overview

We are seeking an experienced GMP Auditor with direct Adeno-Associated Virus (AAV) gene therapy manufacturing experience to conduct comprehensive quality and compliance audits of two Contract Development and Manufacturing Organizations (CDMOs) supporting clinical-stage gene therapy programs.

The primary objective is to assess each CDMO's readiness to support pivotal clinical manufacturing, evaluate the maturity and effectiveness of existing quality systems, and identify compliance gaps against applicable U.S. FDA and EU GMP requirements.

The audits will encompass 21 CFR Parts 210 and 211, EudraLex Volume 4, EU GMP Annex 1, and relevant FDA gene therapy and EMA Advanced Therapy Medicinal Product (ATMP) guidance. Key areas of assessment include AAV manufacturing operations, aseptic processing, contamination control, sterility assurance, laboratory controls, data integrity, and overall GMP quality systems.

The consultant will work alongside a designated co-auditor during both assessments, with particular emphasis on manufacturing deviations, batch failures, reprocessing activities, previous audit findings, and CAPA effectiveness. The engagement requires strong technical auditing capabilities, independent regulatory judgment, and the ability to deliver practical, risk-based recommendations.

Key Responsibilities

• Plan and execute comprehensive, risk-based GMP audits of two CDMO facilities supporting AAV gene therapy clinical manufacturing.

• Collaborate with a designated co-auditor to coordinate audit execution, evaluate observations, and develop findings.

• Assess compliance with applicable FDA and EU GMP requirements, including 21 CFR Parts 210/211, EudraLex Volume 4, and EU GMP Annex 1.

• Evaluate GMP compliance, quality-system maturity, and manufacturing readiness for Phase 1 and pivotal-stage clinical supply.

• Assess AAV upstream and downstream manufacturing controls, in-process testing, batch documentation, and product release practices.

• Review supplier qualification, incoming-material controls, raw-material management, and material traceability.

• Evaluate aseptic processing, contamination control strategies, sterility assurance, and associated qualification and monitoring programs.

• Assess cleanroom controls, environmental monitoring, contamination prevention, and excursion management against applicable Annex 1 expectations.

• Review laboratory controls, analytical testing, atypical results, and investigations of failed testing.

• Evaluate manufacturing deviations, batch failures, reprocessing activities, and associated investigations for potential systemic quality risks.

• Assess quality systems governing deviations, nonconformances, change control, CAPA, management review, and effectiveness verification.

• Evaluate data integrity controls across manufacturing, laboratory, and quality-system activities.

• Review applicable equipment and facility qualification, process validation, storage, handling, and ultra-low-temperature controls.

• Assess previous audit findings, corrective-action history, and manufacturing performance data to identify recurring or unresolved compliance concerns.

• Adapt audit priorities based on facility-specific manufacturing risks and available quality information.

• Document findings with clear explanations of regulatory significance, potential product-quality impact, and recommended remediation priorities.

• Collaborate with the co-auditor to communicate significant findings and provide practical recommendations to strengthen pivotal manufacturing readiness.

Required Qualifications

• Direct experience with AAV gene therapy manufacturing for clinical supply, including GMP expectations applicable to Phase 1 and pivotal-stage programs.

• Significant GMP auditing experience within pharmaceutical or biotechnology manufacturing environments, including cell and gene therapy operations.

• Strong working knowledge of U.S. FDA cGMP requirements, particularly 21 CFR Parts 210 and 211.

• Demonstrated expertise in EU GMP requirements under EudraLex Volume 4, including Annex 1 for sterile medicinal products.

• Familiarity with FDA gene therapy guidance and EMA requirements and guidance applicable to ATMPs.

• Strong understanding of sterile manufacturing, aseptic processing, contamination control strategies, sterility assurance, and environmental monitoring.

• Experience evaluating manufacturing deviations, batch failures, reprocessing activities, investigations, and CAPA effectiveness.

• Strong knowledge of manufacturing controls, laboratory operations, batch release, data integrity, and GMP quality systems.

• Experience conducting comprehensive, risk-based audits of CDMOs or pharmaceutical manufacturing facilities.

• Ability to evaluate AAV manufacturing operations against FDA and EU GMP expectations and identify compliance risks relevant to pivotal clinical development.

• Strong technical writing, communication, and audit-reporting skills, including the ability to develop clear, risk-based remediation recommendations.

• Ability to collaborate effectively with a co-auditor while exercising independent technical judgment.

• Availability for the December 16-17, 2026 onsite audit.

Preferred Qualifications

• Availability to support both the December 2026 and March 2027 audits to maintain consistency in audit methodology and regulatory assessment.