Senior Auditor, Quality Assurance
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What you'll 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 they're looking for
- 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%).
Nice to have
- 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.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Company
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