Clinical Quality Associate Director

Clinical Quality Associate Director

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.

We are committed to pushing the boundaries of science to deliver life-changing medicines. As a Clinical Quality Associate Director (CQAD), you will play a pivotal role in ensuring clinical studies are delivered to the highest standards of quality, compliance and integrity.

Working closely with local Site Management & Monitoring (SMM) leadership and collaborating across regional and global teams, you will act as a trusted quality and compliance advisor. You will help teams navigate complex regulatory requirements, strengthen quality processes, manage risk and continuously improve the way clinical trials are delivered.

This is a highly influential role for someone who enjoys working across functions, solving complex problems and translating quality and regulatory requirements into practical solutions.

As Clinical Quality Associate Director, you will:

• Provide quality and compliance expertise to local study teams, advising on company procedures, ICH-GCP, industry standards and applicable local regulations.
• Monitor the regulatory landscape, ensuring clinical operations teams are kept informed of changes that may impact compliance or study delivery.
• Drive quality oversight and risk management, supporting the planning and execution of local Quality Control activities and identifying opportunities to mitigate compliance risks.
• Support audit and inspection readiness, including preparation, execution, response and follow-up activities, acting as a key local contact for auditors and inspectors.
• Guide teams in addressing audit and inspection findings and support the development and implementation of effective corrective and preventive actions.
• Promote continuous learning by sharing audit and inspection insights locally and across regional quality networks, while bringing global and regional best practices to local teams.
• Identify and address training needs, coordinating or delivering training for SMM colleagues and, where appropriate, investigational site staff.
• Support the implementation of global procedures and systems by providing local expertise, feedback and guidance and escalating relevant issues to regional and global stakeholders.
• Lead or contribute to quality and operational improvement initiatives, including the implementation of systems, tools, SOPs and processes that support compliant and efficient clinical trial delivery.
• Oversee local procedural documents, ensuring they are developed, maintained, trained and archived in alignment with global processes, ICH-GCP and local regulations.
• Act as the primary local interface for Quality Assurance, building strong relationships with Quality, Clinical Operations and other R&D functions.
• Contribute to regional and global quality networks, sharing expertise, best practices and lessons learned.
• Provide expert regulatory and quality input to other departments and represent the organization in relevant professional, regulatory and operational forums.
• Support the evaluation and management of potential fraud or misconduct cases, working with Quality Assurance, regional quality leadership and local management as appropriate.

What you’ll bring

We’re looking for an experienced clinical research or quality professional who can combine strong technical expertise with excellent influencing and communication skills.

You will ideally have:

• A Bachelor’s degree in a relevant discipline, preferably Life Sciences, or an equivalent qualification.
• Previous experience within the pharmaceutical industry, ideally across Clinical Operations, Quality Assurance or a related clinical research function.
• Strong knowledge of the drug development process and GxP requirements, including ICH-GCP and applicable clinical trial regulations.
• Experience with clinical study operations, including monitoring, study drug management, data management and clinical quality oversight.
• Experience supporting or leading audit and regulatory inspection readiness and activities.
• Strong understanding of quality management, risk-based thinking, process management and continuous improvement.
• The ability to interpret complex regulatory and procedural requirements and translate them into practical guidance for operational teams.
• Excellent written and spoken business-level English.
• Strong communication, influencing, training and workshop facilitation skills.
• Excellent problem-solving, critical thinking, decision-making and issue-management capabilities.
• The ability to build trusted relationships and influence stakeholders across functions, cultures and organisational levels.
• A proactive approach to identifying opportunities to improve the quality, efficiency, cost and speed of clinical trial delivery.
• The ability to work effectively across both in-person and virtual environments.
• A high level of integrity, accountability and ethical judgement.
• Willingness and ability to travel nationally and internationally as required.
• A valid driving license, where required by local employment regulations.

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.