Operations Quality Specialist

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🕒 May 15

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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

• This position supports the development and implementation of initiatives and established processes that support operations in maintaining inspection readiness. • This position provides global strategic and tactical leadership within our study teams to achieve overall quality goals while always maintaining inspection readiness. • Creates process and tools to achieve inspection readiness within Development Operations. • Under the leadership of the Operations Quality Lead, develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis. • Provide training or awareness for new or established processes or guidance. • Support overall quality within assigned clinical trials and submissions. • For assigned clinical trials or assets, is point of contact for operational related quality consultation, escalating to QA as needed. • Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends. • Provide training and coaching to promote awareness educating study teams towards quality deliverables. • Support teams in adherence to GCP and procedural documents and processes to ensure quality deliverables.

🎯 Requirements

• Bachelor’s degree or equivalent with a strong emphasis on science or quality management • Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent • Minimum of 3 years’ experience in quality role • Must have working knowledge of ICH GCP and other relevant regulatory/health authority experience • Working knowledge of Quality Management methods, systems, and relevant procedures • Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials • Experience in managing complex and sensitive operational challenges • Experience in risk and issue management and in assessment of non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements • Adept at identifying and investigating issues, identifying root cause, and able to facilitate cross-functional solutions with stakeholders.

🏖️ 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.