Senior Auditor, Quality Assurance

Senior Auditor, Quality Assurance

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.

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 inNvative treatments and therapies.

What you will be doing

• Guiding and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.

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

• Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.

• 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.

• Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.

• Supporting other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.

Your profile

• Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechNlogy, or CRO industry, with at least 2 years in a leadership or senior role.
• In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
• Knowledge / experience in CAPA management, including performing effective root cause analysis
• Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.
• 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.

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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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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