Senior Manager, Quality Assurance

Job not on LinkedIn

🕒 July 17

🔔 Pennsylvania – Remote

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⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 49%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

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 the assigned area • Ensure the team delivers to the highest standards • Develop and implement quality assurance strategies and processes supporting clinical trial activities • Conduct comprehensive quality assessments and audits for compliance with regulatory standards and guidelines • Collaborate with cross-functional teams to identify and address quality issues and implement corrective actions • Participate in the review and approval of clinical trial documentation and data for accuracy and completeness • Provide leadership and mentorship to quality assurance staff • Foster 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 • 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%) • Legal right to work in the country where the role is based

🏖️ 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

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