GCP Auditor

Senior Manager, Quality Assurance ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Senior Manager, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will manage quality assurance and compliance activities across your area, ensuring your team delivers to the highest standards. Key responsibilities include: 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. Your Profile: You will have a strong background in quality assurance and compliance, with proven management experience and a commitment to quality delivery. Required qualifications and experience: 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%) What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here #J-18808-Ljbffr ICON