Senior QA Auditor – GxP & Audit Lead

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

Job summary

Ergomed Group is seeking a Senior Auditor, Quality Assurance to manage and conduct internal and contractor audits for the Company and its Clients. You will influence audit strategy, lead complex audits, and provide QA consultancy within GxP.

The role requires strong pharmacovigilance experience, robust communication skills, and the ability to work across teams to ensure compliance and quality. English fluency is essential, with additional languages a plus.

Qualifications

• Bachelor’s degree in a scientific discipline is required or equivalent.
• Strong experience in pharmaceutical/biotech pharmacovigilance with GVP/GCP knowledge.
• Excellent analytical, written and oral communication skills.
• Ability to manage multiple tasks and deliverables on time.
• Fluent in English; additional languages a plus.

Responsibilities

• Audit internal and contracted audits per the approved Audit Program.
• Lead process and complex audits and provide QA consultancy within GxP.
• Main QA contact for designated Clients; plan, conduct and report audits.
• Support development of audit strategy and risk-based planning; SOPs and guidelines.
• Assist in regulatory inspections and knowledge-sharing across the QA team.

Skills

GxP auditing

Quality assurance

Auditing

Pharmacovigilance

English proficiency

Education

Bachelor's degree in a scientific discipline

Job description

Ergomed Group is seeking a Senior Auditor, Quality Assurance to manage and conduct internal and contractor audits for the Company and its Clients. You will influence audit strategy, lead complex audits, and provide QA consultancy within GxP.

The role requires strong pharmacovigilance experience, robust communication skills, and the ability to work across teams to ensure compliance and quality. English fluency is essential, with additional languages a plus.