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 ICONs 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 work load, 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:

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  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:

• 
  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, 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.

What ICON can offer you:


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.


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