Bilingual GMP Audit (Spain) – Spanish/English (EU GMP / ATMP)

Bilingual GMP Audit Consultant – Spanish/English (EU GMP / ATMP)

Location: Southern Spain
Work Arrangement: Onsite Audit with Remote Preparation Support
Start: Early November 2026
Schedule: 2-Day Onsite Audit, Plus Preparation and Reporting Activities
Travel: Travel to the manufacturing facility in Southern Spain required

Position Overview

We are seeking an experienced bilingual Spanish/English GMP Audit Consultant to support a focused, two-day onsite GMP audit at a life sciences manufacturing facility in Spain.

The facility manufactures an investigational tissue-engineered Advanced Therapy Medicinal Product (ATMP) involving decellularization and recellularization processes. The manufacturing site has received authorization from the Spanish Agency of Medicines and Medical Devices (AEMPS).

The consultant will provide audit preparation, onsite execution, and findings documentation, with a focus on evaluating GMP compliance against applicable European Union (EU) regulatory requirements and supporting inspection readiness.

This engagement requires a consultant with strong EU GMP auditing expertise who can independently assess manufacturing operations, quality systems, and documentation. Because facility documentation is maintained in Spanish, professional fluency in both Spanish and English is essential.

Key Responsibilities

• Plan and prepare for a focused GMP audit, including development of an appropriate audit agenda, scope, and areas of emphasis.

• Conduct a two-day onsite GMP audit of an authorized ATMP manufacturing facility in Spain.

• Evaluate compliance with applicable EU GMP requirements, including relevant expectations for ATMP manufacturing.

• Review GMP procedures, manufacturing records, quality documentation, and supporting records maintained in Spanish.

• Assess GMP controls associated with tissue-engineered ATMP manufacturing, including relevant decellularization and recellularization processes.

• Evaluate key manufacturing practices, quality systems, documentation controls, and inspection-readiness activities.

• Interview facility personnel in Spanish to assess implementation of applicable GMP requirements.

• Identify potential compliance gaps, audit observations, and areas requiring additional attention.

• Evaluate the significance of findings and communicate associated compliance risks.

• Document audit observations and provide practical, risk-based recommendations for follow-up actions.

• Communicate audit findings clearly in English to relevant stakeholders.

Required Qualifications

• Demonstrated experience conducting GMP audits within pharmaceutical