Director, Quality ISO13485

Director, Quality- ISO13485

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.

Director, Quality – ISO13485

We are currently seeking a Director Quality Assurance to join our diverse and dynamic team. As a Director 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

• Leading the development and implementation of quality assurance strategies and processes to support clinical trial activities.

• Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.

• Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.

• Providing expert guidance and support to staff regarding quality assurance policies, procedures, and best practices.

• Contributing to the continuous improvement of quality management systems and documentation.

• Develop, implement, and maintain an ISO 13485-compliant Quality Management System, QA activities, processes, and associated policies and SOPs, that meets regulatory obligations and supports business objectives. 

• Develop and enforce quality assurance policies, procedures, and standards to ensure IVD product quality throughout the manufacturing process. 

• Collaborate with the head of design controls to oversee IVD product testing, inspection, and validation, to confirm that products meet specifications and regulatory requirements. 

• Identify and manage quality risks, including conducting risk assessments and implementing corrective and preventive actions (CAPA) as needed.  

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, with significant experience in a leadership role.

• Extensive 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 complex quality issues.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

Salary Range

$143,944 to $179,930

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.   You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Visit our careers site to read more about the benefits ICON offers

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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.

Salary range: $143,944.00-$179,930.00

Bonus, Com, Stock, Benefits & Disclaimer verbiage:
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance.

Are you a current ICON Employee? Please click here to apply