Senior QA Auditor & GxP Compliance Leader

Ergomed; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Ergomed Group is seeking a Senior Auditor, Quality Assurance to manage and conduct internal and contracted audits for the Company and its Clients, delivering input into audit strategy and risk-based planning. The role includes QA consultancy, cross-functional collaboration, and maintaining up-to-date regulatory knowledge.

You will lead audits across partner sites and vendors, oversee CAPA plans, and support Quality as a Service activities.

Qualifications

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

Responsibilities

• Lead internal and contracted audits for the Company and Clients.
• Provide QA consultancy within the area of GxP expertise.
• Develop audit strategy and risk-based audit planning.
• Maintain knowledge of international regulatory requirements and train Auditors.

Skills

Analytical

Communication

Fluent English

Education

Bachelor's degree in a scientific discipline

Master's degree preferred

Job description

Ergomed Group is seeking a Senior Auditor, Quality Assurance to manage and conduct internal and contracted audits for the Company and its Clients, delivering input into audit strategy and risk-based planning. The role includes QA consultancy, cross-functional collaboration, and maintaining up-to-date regulatory knowledge.

You will lead audits across partner sites and vendors, oversee CAPA plans, and support Quality as a Service activities.