Principal Auditor, Quality Assurance

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.**We are looking for a Principal Quality Assurance Professional to join our Vendor QA team.**Our Vendor QA group is a fabulous team of GxP QA professionals who oversee the quality assurance assessment, onboarding, oversight, qualification and tracking of regulated vendors. Teamwork, can-do spirit and collaboration are the hallmarks of our group. We have fun, laugh, pull together and get it done.With hundreds of vendors from all GxP disciplines, there is no shortage of excitement and opportunity from which to learn and grow. Consider bringing your talent to this dynamic group.**As Principal Quality Professional you will**:- Performing risk assessments for new vendor requests in compliance with regulatory expectations to determine QA qualification requirements for onboarding.- Liaising with auditors (internal & external), sponsors, procurement, operational staff and vendors to develop Audit Scope / Plan and to coordinate qualification, surveillance and for-cause audits of vendors.- Reviewing vendor Audit Reports, Observations along with auditee responses to ensure compliance of vendors and determine qualification status.- Executing Vendor CAPA management (tracking, follow-up, evidence review and closure).- Developing / archiving / maintaining audit documentation e.g. audit scope, audit certificates, ICON official audit records, CAPA documentation.- Assisting with the evaluation, development and issuance of yearly Supplier Audit Schedule and quarterly revisions/updates- Supporting regulatory inspection or sponsor audit requests for vendor qualification evidence.- Contributing to team meetings, respond to regulatory related queries received by Vendor QA and escalate any issues to relevant management for action.- Travel is not expected except in rare or unusual circumstances.**Experience, knowledge. skills requirements**:- Thorough knowledge of GxP regulations for the conduct of clinical trials (GCP essential; some/all of GLP, GMP, GVP, GDP, Medical Devices, CSV desirable).- Familiarity with all aspects of vendor management / oversight.- Excellent planning and organizational skills with the ability to multi-task and prioritize effectively.- Articulate communication and writing skills.- Effective and efficient problem solving.- Ability to own assigned tasks and drive to completion; ability to work independently.**Benefits of Working in ICON**:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.