Manager, Quality Assurance - EU Q&C Audit Defense Team

Manager, Quality Assurance - Remote in Ireland, Poland or Bulgaria

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.

The EU Audit Defense team are seeking an individual to join them as a QA Manager position.  QA Manager will have People Leader responsibilities for oversight of the EU Audit Defense Team.

This is a specialized team responsible for leading client audits of ICON globally for our clinical, PV and technology services.

The team work directly with the client auditors to arrange, prepare for and host the external audit, liaising with the internal ICON team to ensure the client audit expectations are met and that the audit is a success. The team also manage any resulting observations and CAPAs which ensures the external auditor has one central point of contact for the duration of the audit through to closure.

The Audit Defense team have many years’ experience of hosting both on-site audits conducted at ICON facility, as well as hosting remote audits using technology available to ensure the audit scope can still be met remotely. 

As a Manager, 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:

Your focus will be on coordinating quality assurance and compliance delivery, resolving issues, and developing team capability.

Key responsibilities include:

• Developing and implementing quality assurance strategies and processes to support clinical trial activities.
• Conducting quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Collaborating with project teams to identify and address quality issues and implement corrective actions as needed.
• Providing guidance and support to staff regarding quality assurance policies, procedures, and best practices.
• Contributing to the development and maintenance of quality management systems and documentation.

Your Profile:

You will have solid quality assurance and compliance experience, with the ability to manage competing priorities and develop your team.

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.
• 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 resolve quality issues effectively.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Willingness to travel as required (approximately 35%)

#LI-Remote

#LI-MK2

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