Digital Technology Computer System Assurance Expert

argenx

11d • Remote

About The Position

The Digital Technology Computer System Assurance Expert manages the execution of Computer System Assurance (CSA) projects for computerized systems, ensuring compliance with global regulations and internal quality standards. The role translates the enterprise risk-based validation and qualification strategy into actionable project plans and leads teams in creating validation and qualification packages that support data integrity and successful technology implementation.

The position develops and executes risk-based validation plans, manages lifecycle documentation, and leads day-to-day validation testing with project teams, business users, and Digital Quality. It also supports maintaining systems in a validated state through change-control activities and periodic reviews, serves as the primary validation contact for assigned projects, and contributes feedback to improve the CSA process. The role works across cross-functional teams in a dynamic global environment and is expected to provide hands-on guidance, drive outcomes, and support the company’s values.

Requirements

• Experience in a validation role managing validation of GxP computer systems in a biopharmaceutical or medical device company; 5+ years.
• Experience authoring and executing validation deliverables for complex systems, including Validation Plans, IQ/OQ/PQ protocols, and Traceability Matrices; 5+ years.
• Knowledge of the system development lifecycle (SDLC) and project management principles.
• Ability to collaborate effectively within cross-functional teams and networks.
• Demonstrated communication skills in a multicultural and multilingual global environment.
• Demonstrable experience with project management, proactive planning, priority setting, and securing alignment.
• Agility and adaptability, comfort with ambiguity, ability to build trust, and resilience.
• Ability to lead hands-on in a dynamic, complex, and fast-moving environment.
• Outcome-oriented approach and eagerness to continuously learn, self-improve, and develop, including comfort giving and receiving feedback.

Nice To Haves

• Bachelor’s or master’s degree in Life Sciences, Engineering, Computer Science, Information Systems, or a related field preferred.
• Experience leading project teams or managing the work of other validation specialists or contractors.

Responsibilities

• Develop and execute risk-based validation plans for assigned computer system projects in alignment with the enterprise CSA methodology and regulatory expectations.
• Manage the creation and review of project validation lifecycle documentation, including Validation Plans, Test Plans, and Traceability Matrices.
• Lead and manage day-to-day validation testing, coordinating with project teams, business users, and Digital Quality to ensure protocols are followed correctly and on schedule.
• Manage validation activities related to change controls and contribute to periodic reviews to maintain systems in a validated state.
• Act as the primary validation point of contact for assigned projects, providing expert guidance and resolving execution-level challenges.
• Work with project teams to complete validation deliverables on time and to a high standard of quality.
• Provide project-execution feedback to the validation capability lead to support continuous improvement of the risk-based CSA process.
• Provide project teams with direction and support on validation and qualification tasks and activities.
• Develop project-level validation plans and execute validation documentation and testing, including CT, FT, and UAT.
• Translate validation strategy into clear, executable tasks for project teams and stakeholders.

Benefits

• Retirement savings plans.
• Health benefits.
• Other benefits subject to the terms of applicable plans and program guidelines.
• Eligible to participate in short-term and long-term incentive programs, subject to plan terms and applicable policies.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior