Senior QA Auditor – GxP Compliance & Audit Lead

Ergomed Group; Roma; On-site; EUR 65,000 - 90,000; Full time

Job summary

Ergomed Group in Italy seeks a Senior Auditor, Quality Assurance to manage internal and contracted audits with a GxP focus, contributing to risk-based audit planning and QA consultancy.

The role covers audits of partners, vendors, studies, and client programs; you will lead CAPA reviews, train auditors, and help develop the internal audit program while keeping current with regulatory expectations. Fluent English is required; local languages are a plus.

Qualifications

• Strong pharmacovigilance background with GVP & GCP knowledge.
• Experience leading audits for Company and clients in a QA/GxP context.
• Excellent analytical, written and verbal communication skills.

Responsibilities

• Lead and conduct internal and contracted audits across the group and client programs.
• Provide input on audit strategy and risk-based planning; deliver complex audits.
• Act as QA consultant; support CAPA development and training of auditors.
• Maintain up-to-date knowledge of regulatory requirements and best practices.

Skills

Pharmacovigilance experience

Audit leadership

Analytical skills

Communication skills

GxP knowledge

Education

Bachelor’s degree in a scientific discipline

Master’s degree preferred

Job description

Ergomed Group in Italy seeks a Senior Auditor, Quality Assurance to manage internal and contracted audits with a GxP focus, contributing to risk-based audit planning and QA consultancy.

The role covers audits of partners, vendors, studies, and client programs; you will lead CAPA reviews, train auditors, and help develop the internal audit program while keeping current with regulatory expectations. Fluent English is required; local languages are a plus.