Senior QA Auditor: GxP Audit Leader & Quality Advisor

Ergomed; United States; Remote; USD 110,000 - 160,000; Full time

Job summary

Ergomed seeks a Senior Auditor, Quality Assurance to manage internal and contracted audits across GxP areas, providing strategic input to audit planning and risk-based approaches. The role includes leading complex audits, CAPA reviews, and QA consultancy for clients within the pharma/biotech sectors.

The candidate will act as main QA contact for designated clients, support training, SOP drafting, and continuous improvement initiatives while maintaining up-to-date regulatory knowledge.

Qualifications

• Strong pharmacovigilance and QA knowledge in GVP/GCP.
• Auditing experience in an Audit Lead role.
• Ability to manage tasks and deliverables in a timely manner.
• Think strategically with risk-based, proactive problem solving.
• Fluent in English; additional languages are a plus.

Responsibilities

• Manage and conduct internal and contracted audits per Audit Program.
• Lead process and complex audits across GxP areas.
• Provide QA consultancy, SOP development and CAPA reviews.
• Serve as main QA contact for designated clients and audits.
• Support training, gap analyses, and audit strategy documentation.

Skills

QA auditing

Pharmacovigilance experience

Analytical skills

Written and oral communication

Risk-based problem solving

Team player

English fluency

Education

Bachelor's degree in a scientific discipline

Master’s degree preferred or equivalent experience

Job description

Ergomed seeks a Senior Auditor, Quality Assurance to manage internal and contracted audits across GxP areas, providing strategic input to audit planning and risk-based approaches. The role includes leading complex audits, CAPA reviews, and QA consultancy for clients within the pharma/biotech sectors.

The candidate will act as main QA contact for designated clients, support training, SOP drafting, and continuous improvement initiatives while maintaining up-to-date regulatory knowledge.