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.
We are currently seeking a Senior Auditor, Quality Assurance to join our diverse and dynamic team. As a Senior Auditor, Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.
What you will be doing
Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
Contributing to inspection readiness and participating in health authority inspections as needed.
Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
Providing expert guidance and practical recommendations to stakeholders regarding GCP and quality assurance best practices.
Identifying areas for improvement and contributing to the continuous enhancement of QA programs and initiatives.
Your profile
Bachelor’s degree in Life Sciences, Pharmacy, or a related field, or equivalent relevant experience.
Minimum of 5 years of experience in quality assurance, auditing, or inspections within the pharmaceutical, biotechnology, or CRO industry.
Proven experience with GCP’s (Good Clinical Practices), site audits, and clinical quality oversight. (NOT other GxP’s)
Strong understanding of regulatory requirements and quality systems related to clinical research.
Analytical mindset with excellent problem-solving abilities and attention to detail.
Effective communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams.
Advanced English proficiency — fluent in reading, writing, and speaking.
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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:
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
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
