{"id":3498264,"url":"https://alion.io/job/argenx-digital-technology-computer-system-assurance-expert","title":"Digital Technology Computer System Assurance Expert","company":{"id":1805561,"name":"argenx","domain":"argenx.com","url":"https://alion.io/company/argenx","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":13,"ghost_share":0,"stale_share":0.846,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Sales","role_family":"Sales","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":119000,"max_usd":233000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2094},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-29T00:00:00Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-03T06:05:53Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.\nWe are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.\nThis role is responsible for managing the execution of Computer System Assurance\n(CSA) projects for computerized systems, ensuring that projects are delivered in\ncompliance with global regulations and internal quality standards. This position\ntranslates the enterprise risk-based validation/qualification strategy into actionable\nproject plans, leading teams to create robust validation/qualification packages that\nguarantee data integrity and support the successful implementation of technology\nsolutions that enable our business.\nROLES AND RESPONSIBILITIES\nDevelop and execute risk-based validation plans for assigned computer system\nprojects, ensuring alignment with the enterprise CSA methodology and regulatory\nexpectations.\nManage the creation and review of all validation lifecycle documentation for specific\nprojects, including Validation Plans, Test Plans, and Traceability Matrices as per\nprocedure.\nLead and manage the day-to-day execution of validation testing, coordinating with\nproject teams, business users, and Digital Quality to ensure protocols are followed\ncorrectly and on schedule.\nEnsure the validated state of systems is maintained by managing validation activities\nrelated to change controls and contributing to periodic reviews.\nAct as the primary validation point of contact for assigned projects, providing expert\nguidance and resolving execution-level challenges.\nCo-create with project teams to ensure validation deliverables are completed on time\nand with the highest level of quality and excellence.\nSupport the continuous improvement of the risk based CSA process by providing\nfeedback from project execution to the validation capability lead.\nEmpower project teams by providing clear direction and support on all\nvalidation/qualification-related tasks and activities.\nSkilled in developing project-level validation plans and executing the full range of\nvalidation documentation and testing (CT/FT/UAT)\nAbility to act as a connector, translating validation strategy into clear, executable\ntasks for project teams and stakeholders.\nKnowledge of the system development lifecycle (SDLC) and project management\nprinciples.\nAbility to work collaboratively and effectively together within cross-functional teams\nand networks.\nDemonstrated communication skills, within a multi-cultural and multi-lingual global\nenvironment.\nIs agile and demonstrates adaptability, comfort with ambiguity, trust-building, and\nresilience.\nDerives energy from acting as a hands-on leader in a dynamic, complex, and fastmoving\nenvironment.\nDemonstrable experience with project management, proactive planning, priority\nsetting, and securing alignment.\nDrives toward outcomes.\nAmbitious, inquisitive naturally, a quick study, with demonstrated eagerness to\ncontinuously learn, self-improve and develop. This includes being comfortable giving\nand receiving feedback in a diverse environment.\nPassionate and prepared to lead and contribute to our culture, which is driven by our\ncorporate values of co-creation, innovation, empowerment, excellence, and humility.\nEDUCATION, EXPERIENCE AND QUALIFICATIONS\nBachelor’s or Master Degree preferred in Life Sciences, Engineering, Computer\nScience, Information Systems or related fields.\nExperience in a validation role with responsibility for managing the validation of GxP\ncomputer systems in a biopharmaceutical or medical device company. \"5+ Years\"\nExperience authoring and executing a full range of validation deliverables (e.g.,\nValidation Plans, IQ/OQ/PQ protocols, Traceability Matrices,…) for complex systems.\n\"5+ Years\"\nExperience leading project teams or managing the work of other validation specialists\nor contractors is a plus.\n\nFor applicants in the United States: The annual base salary hiring range for this position is $0.00 - $0.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.\nAt argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.\nBefore you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at .\nIf you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at . 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