Home - Based - Mexico Overview ICON plc is a world‑leading healthcare intelligence and clinical research organization, proud to foster an inclusive environment that drives innovation and excellence. We are currently seeking a Quality Assurance Specialist to join our diverse and dynamic team. This role is responsible for supporting quality compliance across ICON’s clinical programmes, with a particular focus on externally manufactured Clinical Trial Materials (CTM), including Finished Drug Product, clinical packaging, and labeling. This role is accountable for batch disposition for Clinical Trials Materials manufactured at CMOs. What You Will Do Support and execute quality oversight activities for Clinical Trial Materials manufactured at external CMOs. Ensure consistent application of quality compliance by aligning daily activities with applicable cGMP regulations (US, EU, and other regions as required). Review batch documentation, supporting data, certificates of analysis, and technical reports for Finished Drug Product, clinical packaging, and labeling. Support batch disposition processes in accordance with established quality procedures and regulatory requirements. Facilitate and support deviation investigations, change controls, CAPAs, investigations, and nonconformance activities related to clinical manufacturing and external supply. Participate in inspection readiness activities and support internal, vendor, and regulatory audits and inspections. Identify, assess, and elevate product‑related quality and regulatory issues and emerging trends. Work closely with Clinical Supply, Regulatory Affairs, Technical Operations, external Qualified Persons (QPs), and other stakeholders involved in external manufacturing and supply. Your Profile Bachelor’s degree in a related field. At least 3 years of relevant QA compliance and/or Quality Product Disposition experience in the pharmaceutical or biotech industry. Working knowledge of cGMP regulations. Experience reviewing manufacturing or clinical documentation. What ICON Can Offer You In addition to a competitive salary, ICON offers a range of benefits designed to support well‑being and work‑life balance for you and your family. Our Benefits Examples 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 independent specialists who support you and your 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. 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 you have a medical condition or disability, and need a reasonable accommodation for any part of the application process or to perform essential job functions, please let us know. #J-18808-Ljbffr