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Risk & Compliance Lead

🔥 13 hours ago

🌐 Poland, India, +2 more countries – Remote

infoinfo

⏰ Full Time

🟠 Senior

🚔 Compliance

Where this job comes from

Posted on ICON plc's careers page, not through a job board

First seen by Remote Rocketship 13 hours ago

Still open on ICON plc's site. Checked 1 hour ago.

Logo of ICON plc

ICON plc

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

• Monitor agreed quality and compliance metrics, identifying risks, trends and outliers and escalating potential non-compliance or areas requiring further action • Provide focused review and analysis of metrics for specific clients or projects when required • Support operational teams with the management of Quality Events, including deviations, Corrective and Preventive Actions (CAPAs) and audit findings • Support investigations and Root Cause Analysis (RCA), helping to identify underlying causes and appropriate corrective and preventive actions • Assist operational teams with audit and inspection readiness, including preparation for and support during client audits and regulatory inspections • Support the effective management and resolution of audit and inspection findings, working collaboratively with relevant stakeholders • Contribute to system and process optimisation initiatives, using quality data and operational insight to identify opportunities for improvement • Work cross-functionally to promote strong risk awareness and a culture of quality, compliance and continuous improvement

🎯 Requirements

• Bachelor’s degree in life sciences, pharmacy, healthcare, law, business, quality, risk management, or a related field • A professional certification in quality, risk management or compliance is an advantage • Relevant experience within Pharmacovigilance, Drug Safety, Quality, Compliance or another regulated pharmaceutical or clinical research environment • A good understanding of regulated operational processes and associated quality and compliance requirements • Experience working with quality metrics, deviations, CAPAs, audit findings and Root Cause Analysis • Exposure to audits, inspections, compliance reviews or inspection-readiness activities • Strong analytical and problem-solving skills, with the ability to identify trends, outliers and areas of potential risk • The ability to work collaboratively with operational teams to investigate issues and develop practical, sustainable solutions • Strong communication and stakeholder management skills, with the confidence to raise and escalate risks appropriately • The ability to manage competing priorities and follow actions through to resolution • A proactive approach to continuous improvement, quality and compliance • 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

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