Clinical Quality Associate Director

ICON

Warsaw or Gdansk, Poland

About the role

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.