Senior Auditor, Quality Assurance

Senior Auditor, Quality Assurance

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.

As a Senior Auditor, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

You will lead on quality assurance and compliance tasks requiring technical depth, with a focus on quality and continuous improvement.

Key responsibilities include:

Managing Quality Issue during its entire life cycle

Development of CAPA for Quality Issues

Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices.

Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.

Contributing to the continuous improvement of quality assurance programs and initiatives.

May need to support regulatory inspections and Sponsor audits of ICON

Your Profile:

You will have a strong foundation in quality assurance and compliance, with the experience to work independently and guide others.

Required qualifications and experience:

Bachelor's degree in a relevant discipline

Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 2 years in a leadership or senior role.

Deeper understanding of Quality Issues and CAPA

Deeper understanding of Quality Management System in CRO environment

In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).

Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.

Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.

Willingness to travel as required, though very minimum

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 about the benefits ICON offers.

Inclusion and Accessibility

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.