Senior Quality Auditor GMP & Clinical Development

Make it in the North; Groningen; Hybrid; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Flexible benefits including childcare,

Job summary

ICON is seeking a Senior Auditor, Quality Assurance to support drug manufacturing operations and ensure GMP compliance across clinical development programs. This role involves leading GMP audits, driving quality improvements, and partnering with cross-functional teams to enable compliant, patient-focused outcomes.

As an experienced QA professional, you will guide internal stakeholders, support study-specific quality activities, and contribute to inspections readiness while travel may be required

Qualifications

• Bachelor's degree in a scientific field or related discipline.
• Significant Quality Assurance experience within pharmaceutical, biotechnology, or CRO industries.
• Strong understanding of clinical research processes and regulatory frameworks.

Responsibilities

• Planning, leading, and conducting GMP-focused audits of processes, systems, vendors, facilities, and documentation.
• Performing study-specific quality assurance activities to support clinical development programs.
• Evaluating compliance with global regulatory requirements, including GMP and ICH guidelines.
• Identifying quality risks and partnering with cross-functional teams to drive CAPAs.
• Providing expert guidance to internal stakeholders on quality systems, compliance expectations, and audit readiness.
• Supporting continuous improvement of ICON's Quality Management System and QA processes.
• Contributing to regulatory inspection readiness activities and follow-up actions.

Skills

GMP audits

QA experience

Regulatory knowledge

Communication skills

Education

Bachelor's degree in science

Job description

ICON is seeking a Senior Auditor, Quality Assurance to support drug manufacturing operations and ensure GMP compliance across clinical development programs. This role involves leading GMP audits, driving quality improvements, and partnering with cross-functional teams to enable compliant, patient-focused outcomes.

As an experienced QA professional, you will guide internal stakeholders, support study-specific quality activities, and contribute to inspections readiness while travel may be required