Digital Technology, Computer System Assurance Expert

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔒 Insurance

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This company has sponsored H1B visas in the past.

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Manage the execution of Computer System Assurance (CSA) projects for computerized systems • Ensure projects comply with global regulations and internal quality standards • Translate the enterprise risk-based validation/qualification strategy into actionable project plans • Lead teams in creating validation/qualification packages that support data integrity and technology implementation • Develop and execute risk-based validation plans for assigned computer system projects • Manage creation and review of validation lifecycle documentation, including Validation Plans, Test Plans, and Traceability Matrices • Lead day-to-day validation testing and coordinate with project teams, business users, and Digital Quality • Maintain the validated state of systems through change-control validation activities and periodic reviews • Serve as the primary validation point of contact for assigned projects • Provide expert guidance and resolve execution-level challenges • Co-create with project teams to complete validation deliverables on time and to high quality standards • Support continuous improvement of the risk-based CSA process by providing project execution feedback • Provide direction and support for validation and qualification tasks

🎯 Requirements

• Bachelor’s or Master Degree preferred in Life Sciences, Engineering, Computer Science, Information Systems or related fields • 5+ years of experience in a validation role managing validation of GxP computer systems in a biopharmaceutical or medical device company • 5+ years of experience authoring and executing validation deliverables, including Validation Plans, IQ/OQ/PQ protocols, and Traceability Matrices, for complex systems • Experience leading project teams or managing the work of validation specialists or contractors is a plus • Skilled in developing project-level validation plans and executing validation documentation and testing (CT/FT/UAT) • Knowledge of the system development lifecycle (SDLC) and project management principles • Demonstrated communication skills in a multicultural and multilingual global environment • Demonstrable experience with project management, proactive planning, priority setting, and securing alignment • Ability to work collaboratively and effectively within cross-functional teams and networks • Adaptability, comfort with ambiguity, trust-building, and resilience • Willingness and ability to continuously learn, self-improve, and develop

🏖️ Benefits

• Short-term and long-term incentive programs, subject to the terms and conditions of the applicable plans and policies • Comprehensive benefits package • Retirement savings plans • Health benefits • Equal consideration for employment without discrimination • Reasonable accommodation during the application, interviewing, and candidate selection process

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