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.
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 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.
At 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.
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