Senior Digital CSA Lead — Systems Validation

Argenx; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

argenx is seeking a role-focused candidate to manage Computer System Assurance (CSA) projects, ensuring validation activities meet regulatory expectations and quality standards. You will translate strategy into actionable plans, lead teams, and ensure data integrity throughout validation lifecycles.

The role emphasizes risk-based validation, collaboration across cross-functional teams, and delivering robust qualification packages for technology implementations within a fast-moving biotech

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.
• 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 CSA methodology and regulatory expectations.
• Manage creation and review of validation lifecycle documentation (Validation Plans, Test Plans, Traceability Matrices).
• Lead and manage day-to-day execution of validation testing, coordinating with project teams and stakeholders.
• Maintain validated state by managing change controls and contributing to periodic reviews.
• Act as primary validation point of contact for assigned projects and provide guidance to teams.

Skills

CSA project management

Education

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

Job description

argenx is seeking a role-focused candidate to manage Computer System Assurance (CSA) projects, ensuring validation activities meet regulatory expectations and quality standards. You will translate strategy into actionable plans, lead teams, and ensure data integrity throughout validation lifecycles.

The role emphasizes risk-based validation, collaboration across cross-functional teams, and delivering robust qualification packages for technology implementations within a fast-moving biotech