Principal Quality Assurance Professional

Principal Quality Assurance Professional - Vendor Management - Mexico - HomebasedICON 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 developmentOur 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.What you will be doing- 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.**Profile**:- BSc degree mandatory (preferably in a Life Science or similar area).- At least 5 years of relevant experience in a regulated environment (preferably within QA, risk-assessment, risk management).- 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.- Excellent or Advanced English level.LI-DT2LI-RemoteWhat 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.Visit ourcareers siteto read more about the benefits ICON offers.