Senior Auditor, Quality Assurance

ICON; Groningen; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance options

Retirement planning offerings

Employee assistance programme (LifeNow

Life assurance

Flexible country-specific benefits

Job summary

ICON plc is seeking a Senior Auditor, Quality Assurance (GMP) to join our global team in Groningen, Netherlands. You will lead GMP audits across manufacturing and clinical development, ensuring regulatory compliance and continuous quality improvement.

This office-based role offers flexible working arrangements and opportunities to influence quality systems and inspection readiness. Ideal candidates hold a scientific degree and have substantial QA experience in pharmaceutical/CRO environments,

Qualifications

• Bachelor's degree in a scientific or related discipline.
• Significant QA 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.
• Willingness to travel internationally as required (~35%).

Responsibilities

• Plan, lead GMP-focused audits of processes, systems, vendors, facilities, and documentation.
• Perform study-specific quality assurance activities to support clinical development programs.
• Evaluate compliance with global regulatory requirements, including GMP, ICH guidelines, and applicable health authority regulations.
• Identify quality risks and partner with cross-functional teams to drive effective corrective and preventive actions.
• Provide expert guidance to internal stakeholders on quality systems, compliance expectations, and audit readiness.
• Support the continuous improvement of ICON's Quality Management System and quality assurance processes.
• Contribute to regulatory inspection readiness activities and follow-up actions as required.

Skills

GMP Audits

QA Leadership

Regulatory Compliance

Stakeholder Management

Education

Bachelor's degree in scientific discipline

Job description

Senior Auditor, Quality Assurance (GMP)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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

As a Senior Auditor, you will take a lead role in delivering quality assurance activities that ensure regulatory compliance and operational excellence across manufacturing and clinical development functions.

Key responsibilities include:

• 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

We're looking for a confident quality professional who combines strong technical expertise with excellent stakeholder management skills.

Required qualifications and experience:

• 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:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

• 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.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here