Senior Auditor, Quality Assurance

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

At ICON, quality is at the heart of everything we do. We're seeking an experienced Senior Auditor, Quality Assurance to join our global team, supporting drug manufacturing operations and ensuring compliance with Good Manufacturing Practice (GMP) standards across clinical development programs. This is an exciting opportunity for a quality professional with a strong background in the pharmaceutical or CRO industry, who understands the complexities of clinical research and is passionate about driving quality, compliance, and continuous improvement. You'll work closely with stakeholders across the business, leading audits and supporting study-specific quality activities that help bring innovative therapies to patients worldwide. This role is office-based with flexible working arrangements available.

What You Will Do

• 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, ICH guidelines, and applicable health authority regulations.
• Identifying quality risks and partnering with cross-functional teams to drive effective corrective and preventive actions.
• Providing expert guidance to internal stakeholders on quality systems, compliance expectations, and audit readiness.
• Supporting the continuous improvement of ICON's Quality Management System and quality assurance processes.
• Contributing to regulatory inspection readiness activities and follow-up actions as required.

What You'll Bring

• Bachelor's degree in a scientific or related discipline.
• Significant Quality Assurance experience within the pharmaceutical, biotechnology, or CRO industry.
• Strong understanding of clinical research processes and the regulatory framework governing clinical development.
• Demonstrable experience conducting and leading GMP audits.
• Thorough knowledge of global GMP requirements and quality management systems.
• Strong analytical, problem-solving, and risk assessment skills.
• Excellent communication skills with the ability to influence and engage stakeholders at all levels.
• Willingness to travel internationally as required (approximately 35%).

Preferred Experience

• Formal auditor qualifications or additional training/certification in auditing.
• Experience supporting both manufacturing operations and clinical research environments.
• Exposure to global regulatory inspections and supplier/vendor auditing programs.

What ICON can offer you:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.