Senior Manager, Quality Assurance

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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

• Manage confirmed Major / Critical Quality Event (QE) cases through investigation process including root cause analysis • Ensure investigations are conducted thoroughly within required timelines and compliance requirements • Direct the QE team in proposing appropriate Corrective and Preventative Actions • Manage Critical and complex cases requiring presentation to senior leaders as part of the Quality Review Team (QRT) • Drive GCP quality in withstanding regulatory scrutiny, operational data, and documentation • Audit coordination for GCP related processes and preferred CRO vendor audits • Direct Inspection readiness and providing inspection support for GCP sponsor inspection activities • Mentor and train Issue Leads to ensure individuals are qualified to assess and categorize submitted Quality Events • Plan, lead and report out on Quality and Compliance Assessments related to CD&O processes • Serve as the point of contact for Regulatory Quality Assurance related to audit and inspection

🎯 Requirements

• 10+ years’ experience or equivalent with BS or 9+ years’ experience or equivalent with MBA/MS • Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory • Regulatory inspection experience • Process and system management experience • Detailed knowledge of clinical trial processes and relationships required • Knowledge of GCP requirements and applicable SOPs and regulations • Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills • Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

🏖️ 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