Clinical Quality Associate Director

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Provide quality and compliance expertise to local study teams on company procedures, ICH-GCP, industry standards and local regulations • Monitor the regulatory landscape and inform clinical operations teams of compliance or study-delivery changes • Drive quality oversight and risk management, including local Quality Control activities and compliance-risk mitigation • Support audit and inspection readiness, preparation, execution, responses and follow-up • Guide teams in addressing audit and inspection findings and implementing corrective and preventive actions • Share audit and inspection insights and bring global and regional best practices to local teams • Identify and coordinate or deliver training for SMM colleagues and investigational site staff • Support implementation of global procedures and systems through local expertise, feedback and guidance • Lead or contribute to quality and operational improvement initiatives involving systems, tools, SOPs and processes • Oversee local procedural documents, including development, maintenance, training and archiving • Act as the primary local interface for Quality Assurance and build relationships across Quality, Clinical Operations and R&D • Contribute to regional and global quality networks • Provide regulatory and quality input to other departments and represent the organization in relevant forums • Support evaluation and management of potential fraud or misconduct cases

🎯 Requirements

• Bachelor’s degree in a relevant discipline, preferably Life Sciences, or an equivalent qualification • Previous experience within the pharmaceutical industry, ideally in Clinical Operations, Quality Assurance or related clinical research • 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 • Ability to interpret complex regulatory and procedural requirements and translate them into practical operational guidance • 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 • Ability to build trusted relationships and influence stakeholders across functions, cultures and organisational levels • Proactive approach to improving the quality, efficiency, cost and speed of clinical trial delivery • Ability to work effectively across in-person and virtual environments • High level of integrity, accountability and ethical judgement • Willingness and ability to travel nationally and internationally as required • Valid driving license where required by local employment regulations • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways • Inclusive and accessible workplace • Reasonable accommodations during the recruitment process