Senior QA Auditor - GxP & Compliance Lead

Ergomed; England; On-site; GBP 55,000 - 75,000; Full time

Job summary

Ergomed Group is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across GxP, driving risk-based assurance for the company and clients.

You will provide QA consultancy, develop CAPA plans, and train auditors, collaborating with global teams to strengthen regulatory readiness and data integrity.

Fluency in English is essential; pharma/biotech pharmacovigilance experience is advantageous.

Qualifications

• Bachelor’s degree in a scientific discipline; Master’s degree preferred.
• Strong pharma/biotech pharmacovigilance experience.
• GVP and GCP QA auditing experience in an Audit Lead role.
• Excellent analytical, written and oral communication.
• Ability to manage multiple tasks with timely delivery.
• Fluent in English; additional languages a plus.

Responsibilities

• Conduct audits per Audit Program including pre-audit activities.
• Audit types: partner/vendor/internal/system/study audits.
• Provide QA consultancy: CAPA, SOP drafting and revision.
• Main QA contact for designated Clients; report on audits.
• Support audits/inspections by regulatory authorities.
• Develop and train Auditors; contribute to internal audit program.

Skills

Pharmacovigilance

GVP knowledge

GCP auditing

Audit leadership

Analytical skills

Team player

English fluent

Education

Bachelor’s degree in a scientific discipline

Master’s degree preferred

Job description

Ergomed Group is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across GxP, driving risk-based assurance for the company and clients.

You will provide QA consultancy, develop CAPA plans, and train auditors, collaborating with global teams to strengthen regulatory readiness and data integrity.

Fluency in English is essential; pharma/biotech pharmacovigilance experience is advantageous.