Clinical Quality Compliance Lead

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🕒 May 13

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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 to ensure compliance with regulatory requirements, industry standards, and company policies. • Lead internal and external audits and inspections, including planning, execution, and follow-up activities to address findings and ensure timely resolution. • Conduct regular quality reviews of clinical trial documentation, protocols, and study reports, identifying areas for improvement and implementing corrective actions as necessary. • 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, develop risk mitigation strategies, and 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, with the ability to effectively prioritize tasks and manage resources to meet objectives. • Excellent communication, interpersonal, and problem-solving skills, with the ability to influence and collaborate with stakeholders at all levels of the organization. • Willingness to travel to site as required about once per month.

🏖️ Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.