Experience: 10–12 years of experience in GMP-regulated environments Insud Pharma operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health. Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with 10,000 professionals in more than 50 countries, 20 industrial plants, 15 specialized R&D; centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in over 110 countries worldwide. We are looking for a GMP Quality Auditor to join our team in Madrid.

Reporting to the GMP Quality Audit Regional Manager, this role will play a key part in performing global GxP quality audits and supporting the development of an effective global risk-based audit strategy and program. We are looking for a highly experienced professional with a strong background in GxP auditing within the pharmaceutical industry, able to lead complex global audits, assess risks in critical operations, and ensure full compliance with Insud Pharma's quality procedures and applicable regulations. Support the strategic development of an effective global risk-based audit strategy and program.

Collect, collate, and incorporate relevant input into the audit strategy and planning process. Plan, lead, conduct, document,



and follow up on GMP audits in accordance with Insud Pharma Quality procedures, applicable regulations, standards, quality agreements, and guidance documents. Prepare audit reports in line with Insud Pharma Quality procedures and established timelines.

Ensure proper escalation to responsible management in the event of critical findings, and support immediate follow-up actions in accordance with Insud Pharma Quality procedures on escalation management and other relevant procedures. Assess the adequacy of responses and CAPA plans related to audit findings in cooperation with stakeholder QA representatives and auditees. Identify and report best practices and lessons learned to support the development and training of GMP auditors.

Specific expertise in Quality Control / laboratory systems, including LIMS. Solid understanding of applicable regulations, standards, quality systems, and guidance documents. Excellent written and verbal communication skills in English.

Knowledge of Spanish will be considered a plus. The opportunity to join a solid and growing international pharmaceutical company. A integral role within a highly regulated and high-impact quality environment.

A strategic position with visibility and responsibility in global audit activities. Ongoing professional development in a demanding, technical, and innovative environment. All applications will be considered regardless of gender, gender identity or expression, age, ethnicity, nationality, religion, sexual orientation, disability, or any other personal, physical, or social condition.

📌 Compliance Auditor (Madrid)
🏢 Insud Pharma
📍 Madrid