Senior QA Auditor - GxP Compliance & Audit Leader

Ergomed Group; Guildford; Sur place; GBP 65 000 - 90 000; Plein temps

Résumé du poste

Ergomed Group is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across GxP areas for our biopharmaceutical clients. You will shape audit strategy and ensure timely CAPA delivery while partnering with client teams globally.

The role requires strong pharmacovigilance and GVP/GCP auditing expertise, with proven audit leadership and collaboration across cross-functional teams. English fluency and a chemistry/biological science background are essential.

Qualifications

• Bachelor’s degree in a scientific discipline required; Master’s degree preferred, or equivalent relevant industry experience.

Responsabilités

• Auditing across internal and contracted audits in GxP.
• Conduct audits within GxP area per Audit Program and pre-audit activities.
• Audit types include Partners and Vendors/Service Providers; Internal System Audits.
• Study audits including investigational sites; Third-party audits for Clients.
• Reviews and approves final CAPA plans from contracted audits within timelines.
• Be the main QA contact for designated Clients and QA services.
• Support Quality as a Service activities: training, gap analysis, SOP drafting.

Connaissances

Pharmacovigilance

GVP auditing

GCP auditing

Audit leadership

Formation

Bachelor’s degree in scientific discipline

Master’s degree preferred

Description du poste

Ergomed Group is seeking a Senior Auditor, Quality Assurance to lead internal and contracted audits across GxP areas for our biopharmaceutical clients. You will shape audit strategy and ensure timely CAPA delivery while partnering with client teams globally.

The role requires strong pharmacovigilance and GVP/GCP auditing expertise, with proven audit leadership and collaboration across cross-functional teams. English fluency and a chemistry/biological science background are essential.