Senior QA Auditor — GxP & Regulatory Compliance

Ergomed Group; Lisboa; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

Ergomed Group is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across the company and client sites. You will shape audit strategy, manage risk-based planning and deliver complex audits within GxP.

The role requires a scientific bachelor’s (master’s preferred), strong pharmacovigilance experience in GVP/GCP, and fluent English. You will mentor auditors, maintain regulatory knowledge, and collaborate across global teams to protect patient safety.

Qualifications

• Bachelor’s degree in a scientific discipline required; Master’s degree preferred or equivalent experience.
• Strong pharmacovigilance experience with GVP/GCP knowledge in QA/assurance; auditing experience as Audit Lead.

Responsibilities

• Audit Company Partners and Vendors/Service Providers per the Audit Program.
• Main QA contact for designated Clients; plan, conduct and report audits.
• Provide QA as a Service: mock inspections, training, gap analysis, procedure drafting and revision.
• Support audits and inspections by Clients/regulatory authorities; develop auditors and internal programs.

Skills

GxP auditing

GVP/GCP knowledge

Analytical skills

English fluency

Education

Bachelor’s degree in science

Master’s degree preferred

Job description

Ergomed Group is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across the company and client sites. You will shape audit strategy, manage risk-based planning and deliver complex audits within GxP.

The role requires a scientific bachelor’s (master’s preferred), strong pharmacovigilance experience in GVP/GCP, and fluent English. You will mentor auditors, maintain regulatory knowledge, and collaborate across global teams to protect patient safety.