Clinical QA Manager

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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

• Responsible for ensuring robust oversight of clinical trial compliance at the country and site level • Apply a risk-based approach to proactively identify, evaluate, and manage compliance risks • Ensure adherence to Good Clinical Practice (GCP), company procedures, and regulatory requirements • Partner closely with country, regional and global stakeholders to safeguard patient safety, data integrity, and inspection readiness • Coordinate clinical quality assurance and compliance delivery, resolving issues, and developing team capability • Develop and implement quality assurance strategies and processes to support clinical trial activities • Conduct quality assessments and audits to ensure compliance with regulatory standards and guidelines • Collaborate with project teams to identify and address quality issues and implement corrective actions as needed • Provide guidance and support to staff regarding quality assurance policies, procedures, and best practices • Contribute to the development and maintenance of quality management systems and documentation

🎯 Requirements

• Bachelor's degree in a relevant discipline • Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry • Knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations) • Strong analytical and problem-solving skills, with the ability to identify and resolve quality issues effectively • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders • Willingness to travel as required (approximately 35%)

🏖️ 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