Senior Auditor, Quality Assurance

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.