PrincipalQASpecialist

Working within the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and compliant. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal company policies and procedures. **As a Principal QA Specialist, a typical day might include the following:** * Supporting IT related change controls, CAPAs, data integrity initiatives, deviations, internal and external audits and other verticals to ensure a robust, compliant state of programs * Engaging with Corporate and IOPS IT ensuring IT processes and procedures meet Regeneron’s Quality System requirements * Reviewing, editing and approving SOPs, deviation notifications, deviation investigations, and corrective actions * Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions * Collaborating, investigating and troubleshooting to determine solutions or recommendations for changes and/or improvements * Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives * Supporting the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process * Contributing information reflecting best practices, industry trends and recommendations for strategic plans to drives changes and improvements * Communicating project and program status and metrics to Senior Management **This role might be for you if you:** * Demonstrate strong interpersonal skills and can collaborate effectively * Can balance changing priorities with a growing workload by communicating timely decisions * Demonstrate knowledge of 21CFR11 and Annex 11 as well MHRA, FDA and WHO data integrity guidelines * Have an understanding of the interdependencies of change management, d