Manager, Quality Assurance

Manager, Quality Assurance - Home or Office - Bulgaria, Poland, South Africa

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 Q&C Manager role will be responsible for overseeing ICON's client site audit process, including line management of the external site audit team. Roles and responsibilities will include, but not be limited to oversight of incoming site audit workload, supporting project teams and the auditors with the finding responses, RCA and CAPA development, overseeing quality of records in the QMS and leading CAPA development for any critical issues.

This role will work closely with ICON’s clinical operations teams to support process improvements and trending of external site audit data. The right candidate will have previous experience with CAPA development, strong root cause analysis skills and some knowledge of site audit processes. Previous line management experience is preferable, but not essential.

As a Manager 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:

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

Your profile:

1. Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
2. Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry.
3. Knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
4. Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues effectively.
5. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

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, TELUS Health, 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.

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 organization. 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.