Key Skills

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. Our Benefits Examples Include 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. Visit our careers site to read more about the benefits ICON offers. 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 Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Core Responsibilities

Lead GMP-focused audits of processes, systems, and vendors to ensure regulatory compliance across manufacturing and clinical development. Partner with cross-functional teams to identify quality risks and drive continuous improvement of the Quality Management System.

Requirements

Requires a bachelor's degree in a scientific discipline and significant QA experience within the pharmaceutical, biotech, or CRO industry. Must have demonstrable experience leading GMP audits and a willingness to travel internationally approximately 35% of the time.

Benefits

• Annual Leave
• Health Insurance
• Retirement Planning
• Employee Assistance Programme
• Life Assurance
• Childcare Vouchers
• Bike Purchase Schemes
• Discounted Gym Memberships
• Subsidized Travel Passes
• Health Assessments