Digital Technology Computer System Assurance Expert

argenx US; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

argenx US is seeking a knowledgeable CSA professional to manage validation projects across a wide enterprise scope, ensuring compliance with global regulations and quality standards. You will translate risk-based validation strategies into actionable project plans and lead teams to deliver robust validation packages that safeguard data integrity.

The role emphasizes collaboration with cross-functional teams, SDLC expertise, and hands-on leadership in a fast-moving biopharma environment.

Qualifications

• Bachelor's or Master Degree preferred in Life Sciences, Engineering, Computer Science, Information Systems or related fields.
• Experience in a validation role with responsibility for managing the validation of GxP computer systems in a biopharma or medical device company. 5+ Years
• Experience authoring and executing a full range of validation deliverables (e.g., Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices,...) for complex systems. 5+ Years
• Experience leading project teams or managing the work of other validation specialists or contractors is a plus.

Responsibilities

• Develop and execute risk-based validation plans for assigned computer system projects, ensuring alignment with the enterprise CSA methodology and regulatory expectations.
• Manage the creation and review of all validation lifecycle documentation for specific projects, including Validation Plans, Test Plans, and Traceability Matrices as per procedure.
• Lead and manage the day-to-day execution of validation testing, coordinating with project teams, business users, and Digital Quality to ensure protocols are followed correctly and on schedule.
• Ensure the validated state of systems is maintained by managing validation activities related to change controls and contributing to periodic reviews.
• Act as the primary validation point of contact for assigned projects, providing expert guidance and resolving execution-level challenges.

Skills

CSA knowledge

Validation testing

SDLC familiarity

Cross-functional collaboration

Education

Bachelor's or Master's in Life Sciences/Engineering/CS

GxP validation experience

Tools

IQ/OQ/PQ protocols

Traceability matrices

Job 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.

We 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.

This role is responsible for managing the execution of Computer System Assurance (CSA) projects for computerized systems, ensuring that projects are delivered in compliance with global regulations and internal quality standards. This position translates the enterprise risk-based validation/qualification strategy into actionable project plans, leading teams to create robust validation/qualification packages that guarantee data integrity and support the successful implementation of technology solutions that enable our business.

ROLES AND RESPONSIBILITIES

• Develop and execute risk-based validation plans for assigned computer system projects, ensuring alignment with the enterprise CSA methodology and regulatory expectations.
• Manage the creation and review of all validation lifecycle documentation for specific projects, including Validation Plans, Test Plans, and Traceability Matrices as per procedure.
• Lead and manage the day-to-day execution of validation testing, coordinating with project teams, business users, and Digital Quality to ensure protocols are followed correctly and on schedule.
• Ensure the validated state of systems is maintained by managing validation activities related to change controls and contributing to periodic reviews.
• Act as the primary validation point of contact for assigned projects, providing expert guidance and resolving execution-level challenges.
• Co-create with project teams to ensure validation deliverables are completed on time and with the highest level of quality and excellence.
• Support the continuous improvement of the risk based CSA process by providing feedback from project execution to the validation capability lead.
• Empower project teams by providing clear direction and support on all validation/qualification-related tasks and activities.
• Skilled in developing project-level validation plans and executing the full range of validation documentation and testing (CT/FT/UAT)
• Ability to act as a connector, translating validation strategy into clear, executable tasks for project teams and stakeholders.
• Knowledge of the system development lifecycle (SDLC) and project management principles.
• Ability to work collaboratively and effectively together within cross-functional teams and networks.
• Demonstrated communication skills, within a multi-cultural and multi-lingual global environment.
• Is agile and demonstrates adaptability, comfort with ambiguity, trust-building, and resilience.
• Derives energy from acting as a hands-on leader in a dynamic, complex, and fastmoving environment.
• Demonstrable experience with project management, proactive planning, priority setting, and securing alignment.
• Drives toward outcomes.
• Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness to continuously learn, self-improve and develop. This includes being comfortable giving and receiving feedback in a diverse environment.
• Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility.

EDUCATION, EXPERIENCE AND QUALIFICATIONS

• Bachelor's or Master Degree preferred in Life Sciences, Engineering, Computer Science, Information Systems or related fields.
• Experience in a validation role with responsibility for managing the validation of GxP computer systems in a biopharmaceutical or medical device company. "5+ Years"
• Experience authoring and executing a full range of validation deliverables (e.g., Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices,...) for complex systems. "5+ Years"
• Experience leading project teams or managing the work of other validation specialists or contractors is a plus.

#LI-remote

For 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 a