Senior Manager, Quality Assurance

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🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (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 quality assurance and compliance activities across your area, ensuring your team delivers to the highest standards • Developing and implementing quality assurance strategies and processes to support clinical trial activities • Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines • Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed • Participating in the review and approval of clinical trial documentation and data to ensure accuracy and completeness • Providing leadership and mentorship to quality assurance staff, fostering a culture of excellence and continuous improvement

🎯 Requirements

• Bachelor's degree in a relevant discipline • Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a management or leadership role • Strong knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations) • Excellent analytical and problem-solving skills, with the ability to identify and resolve complex quality issues • Exceptional communication and interpersonal skills, with the ability to collaborate effectively with colleagues and stakeholders at all levels • 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