Associate Director, Computer Software Assurance and Validation Expert

1 day ago


Plainsboro, New Jersey, United States Genmab Full time
Job Overview

Genmab is seeking an experienced Associate Director to lead the development and implementation of advanced validation strategies for computer software assurance and validation. This role will be responsible for elevating our validation processes using cutting-edge technologies such as Generative AI, unscripted testing, and automation.

Key Responsibilities:

  • Develop and implement validation strategies incorporating GenAI to streamline validation processes.
  • Design and execute validation protocols and standards (IQ/OQ/PQ) for new and existing equipment and systems.
  • Define the systems/toolsets needed to maintain validated state of our digital products and platforms, while operating in an agile and product-based delivery model.

Requirements:

  • 10 years of proven experience in validation and software assurance/QA within the pharmaceutical or biotech industry.
  • Strong track record in implementing advanced validation methods and automation.
  • Experience with managing GxP systems, DevSecOps, Agile methodologies, operating within the Atlassian suite, and a product-based delivery model.

Preferred Skills:

  • Certifications in relevant fields such as Computer System Validation (CSV) or Computer Software Assurance (CSA).
  • Experience in the biotechnology or pharmaceutical industry is an added advantage.
  • Strong written and verbal communication skills.
  • Ability to multi-task and work with global teams.

Why Genmab?

  • Opportunity to work with cutting-edge technologies and innovative solutions.
  • Be part of a dynamic team that is transforming validation processes in the biotech industry.
  • Competitive salary and comprehensive benefits package.
  • Career growth opportunities and continuous professional development.


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