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

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

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.

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%)

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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:

• 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