Description
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a Senior Auditor, Quality Assurance, you will take a lead role in delivering quality assurance activities that ensure regulatory compliance and operational excellence across manufacturing and clinical development functions.
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, 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.
Requirements:
- 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.
Rewards & Benefits:
- Competitive base salary and performance-related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways