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.ResponsibilitiesSupporting IT related change controls, CAPAs, data integrity initiatives, deviations, internal and external audits and other verticals to ensure a robust, compliant state of programsEngaging with Corporate and IOPS IT to ensure IT processes and procedures meet Regeneron’s Quality System requirementsReviewing, editing and approving SOPs, deviation notifications, deviation investigations, and corrective actionsResponsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actionsCollaborating, investigating and troubleshooting to determine solutions or recommendations for changes and/or improvementsParticipating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiativesSupporting the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) processContributing information reflecting best practices, industry trends and recommendations for strategic plans to drive changes and improvementsCommunicating project and program status and metrics to Senior ManagementQualificationsDemonstrate strong interpersonal skills and can collaborate effectivelyCan balance changing priorities with a growing workload by communicating timely decisionsDemonstrate knowledge of 21CFR11 and Annex 11 as well as MHRA, FDA and WHO data integrity guidelinesHave an understanding of the interdependencies of change management, deviation and continuous improvementCan work in a dynamic organization where innovative solutions are required to ensure a high‑level of quality is achieved with aggressive timelinesBSc/BA/BEng in IT/Automation/Analytics or related field and 5‑7 years of experience or equivalent combination of education and experienceRecent experience in a data integrity role is preferred; however, it is not requiredBenefitsHealth and wellness programs including medical, dental, vision, life, and disability insuranceFitness centers401(k) company matchFamily support benefitsEquity awardsAnnual bonusesPaid time off and paid leaves (e.g., military and parental leave) for eligible employees at all levelsFor additional information about Regeneron benefits in the U.S.: https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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