Clinical Quality Compliance Lead

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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

• Oversee quality assurance and compliance workstreams, ensuring deliverables meet quality and timeline expectations • Develop and implement comprehensive quality management systems and processes • Lead internal and external audits and inspections, including planning, execution, and follow-up activities • Address audit and inspection findings and ensure timely resolution • Conduct regular quality reviews of clinical trial documentation, protocols, and study reports • Identify areas for improvement and implement corrective actions • Provide leadership and guidance to the clinical quality compliance team, including training, mentoring, and performance management • Collaborate with cross-functional teams to assess quality risks and develop risk mitigation strategies • Drive continuous improvement initiatives

🎯 Requirements

• Bachelor's degree or higher in a relevant scientific discipline or healthcare-related field • Previous experience in clinical quality assurance or compliance within the pharmaceutical, biotechnology, or CRO industry • Expert knowledge of regulatory requirements, including FDA/EMA regulations, ICH-GCP guidelines, and ISO standards • Strong leadership and project management skills • Ability to effectively prioritize tasks and manage resources to meet objectives • Excellent communication, interpersonal, and problem-solving skills • Ability to influence and collaborate with stakeholders at all levels of the organization • Willingness to travel as required, approximately 65% • 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