Senior Global GMP Quality Auditor – Pharma

Insud Pharma; Madrid; On-site; EUR 65,000 - 90,000; Full time

Job summary

Insud Pharma in Madrid is seeking a GMP Quality Auditor with a strong track record in GxP auditing within the pharmaceutical industry to lead global audits and support a risk-based strategy. Reporting to the GMP Quality Audit Regional Manager, you will plan, conduct, document, and follow up audits, assess risks in critical operations, and ensure compliance with EU and FDA regulations.

The role requires 10–12 years of GMP experience and an advanced degree in Chemistry/Pharmacy/Chemical

Qualifications

• Advanced degree required in Chemistry, Pharmacy, Chemical Engineering, or related field.
• 10–12 years of experience in GMP-regulated environments and GxP auditing.
• Strong knowledge of EU and FDA regulations for R&D, manufacturing, distribution of pharmaceutical products.
• Experience with QA/Lab systems incl. LIMS.
• Ability to assess risks in complex, high-impact operations.

Responsibilities

• Plan, conduct, document, and follow up GMP audits according to Insud Pharma procedures.
• Lead complex, high-risk audits including sterile API and aseptic processes.
• Assess risks and ensure robust audit approaches across sites.
• Provide technical guidance on audit activities and escalation when needed.
• Prepare audit reports within established timelines and manage CAPA follow-up.

Skills

GxP auditing

GMP knowledge

Quality systems

Risk assessment

Communication

Stakeholder management

Travel up to 70%

Education

Advanced University Degree in Chemistry, Pharmacy, Chemical Engineering, or related field

Tools

LIMS

Regulatory databases

Job description

Insud Pharma in Madrid is seeking a GMP Quality Auditor with a strong track record in GxP auditing within the pharmaceutical industry to lead global audits and support a risk-based strategy. Reporting to the GMP Quality Audit Regional Manager, you will plan, conduct, document, and follow up audits, assess risks in critical operations, and ensure compliance with EU and FDA regulations.

The role requires 10–12 years of GMP experience and an advanced degree in Chemistry/Pharmacy/Chemical