Ergomed seeks a Senior Auditor in Quality Assurance to lead internal and external audits for the company and its clients in the pharmaceutical and biotech sector. The role involves conducting GxP audits, developing audit strategy, providing quality consulting services, and supporting regulatory compliance across multiple audit types and client engagements.

Responsibilities

Conduct internal and contracted audits for company and clients per agreed audit programs

Lead audits of vendors, internal systems, investigational sites, and third-party partners

Review and approve CAPA plans from contracted audits within mandated timelines

Provide quality consulting services including gap analysis and SOP development

Serve as primary QA contact for designated clients and support quality-as-a-service activities

Requirements

Bachelor's degree in a scientific discipline; Master's degree preferred

Extensive pharmaceutical or biotech pharmacovigilance experience

Proven GVP and GCP audit lead experience

Strong written and oral communication skills

Analytical ability and strategic problem-solving approach

Fluent in English; additional languages beneficial

Ability to manage multiple deliverables and meet deadlines

📌 Senior Auditor - QA Compliance (Roma)
🏢 Ergomed
📍 Roma