Auditor, Quality Assurance

4 weeks ago

Dublin, Dublin City, Ireland icon Full time
  • Mexico City, Sofia, Dublin, Warsaw, Bucharest
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives. Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the Clinical Research Organisation that excels in delivering quality to our clients and patients at every touchpoint. In essence, our vision is to be the preferred partner in drug development. This vision propels us forward, and we are in search of skilled individuals who resonate with it.
If you're as determined as we are, come join us. You'll be part of a lively and supportive setting, surrounded by some of the brightest and most approachable professionals in the field, contributing to shaping an entire industry. The role: We are currently looking for a Senior Auditor Quality Assurance to join our varied, lively, and enthusiastic Tech QA team. As a Senior Auditor Quality Assurance, you will have a crucial role in ensuring trial quality and compliance, deciphering regulatory requirements, and contributing to the progress of innovative treatments and therapies. What you will be doing: Leveraging expert knowledge of regulatory expectations and industry insights, you will deliver expert consultancy and compliance guidance within ICON on present and emerging technology-related matters, such as eClinical Systems and AI. You'll engage in a range of audit tasks, including internal process audits with a technological aspect, audits of technology vendors, as well as audits of computerized systems and equipment. You'll conduct Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems. You will also serve as a Subject Matter Expert in Technology during inspections, sponsor audits, and to address Quality Issues. Additionally, you'll play a role in mentoring and training junior staff. Your profile: You should hold a Bachelor's degree in Life Sciences, Pharmacy, IT, or a related field, with a preference for an advanced degree. You should have a minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare, or CRO industry. Your skill set should include strong analytical and problem-solving abilities, along with the capability to identify and resolve complex quality issues spanning multiple systems and business areas. Your experience should demonstrate auditing proficiency in computerized systems, processes, and vendors used in clinical development and manufacturing environments. You should possess in-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks, and emerging trends such as 21 CFR Part 11, Annex 11 & EMA Guidance, Computer Software Assurance, Agile, ITIL, GDPR, Information Security, and AI. Being familiar with regulations and guidelines governing clinical trials and drug development (e.g., ICH, FDA, EMA covering GLP, GCP, GVP, GMP, GDP, and Medical Devices) is essential. Moreover, excellent communication and interpersonal skills are key, enabling effective interaction with internal and external stakeholders across all levels. A willingness to travel more than 20% is required.
Benefits of Working in ICON:
Our achievements rely on the quality of our team members. This is why we've made it a priority to establish a culture that recognizes exceptional performance and fosters talent. We offer highly competitive salary packages, regularly benchmarked against industry counterparts. Our annual bonuses are a reflection of meeting performance targets – both yours and ours. We provide an array of health-related benefits for employees and their families, as well as competitive retirement plans and associated benefits like life assurance, enabling you to save and prepare for the future with confidence. Beyond the attractive salaries and comprehensive benefits, you will thrive in an environment that encourages you to fulfill your sense of purpose and instigate lasting change. ICON is a fair and inclusive employer committed to maintaining a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment irrespective of race, color, religion, gender, sexual orientation, nationality, disability, or veteran status. If you require a reasonable accommodation during any part of the application process due to a medical condition or disability, or to perform essential job functions, please inform us through the form provided below. A better career. A better world. A better you.

Our people are our greatest asset, forming the foundation of our culture and the impetus behind our triumphs. At every level of the organization, our team members exhibit a determination to excel and a commitment to ensuring that our work is done superbly. We support you in building fulfilling and thrilling careers, producing results that facilitate the introduction of groundbreaking medicines and devices to the market, and preserving ICON's standing as an industry frontrunner.
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