Associate Director, Computer Software Assurance and Validation Expert

4 weeks ago


Plainsboro, New Jersey, United States Genmab Full time

About the Role

We are seeking an experienced Associate Director to lead our validation processes using advanced technologies such as Generative AI (GenAI), unscripted testing, and automation. This role is crucial for maintaining the highest standards of quality and compliance, adhering to key regulatory guidelines from relevant authorities.

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.
  • Utilize unscripted testing and risk-based validation methods to ensure compliance and efficiency.
  • Implement and maintain automated validation solutions to enhance process efficiency.
  • Apply the FDA's new CSA guidelines to reduce documentation burdens while maintaining product quality and safety.
  • Compile and analyze validation data using advanced data analytics and machine learning techniques.
  • Prepare comprehensive validation reports and make recommendations for process improvements.

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.
  • Proficiency in utilizing GenAI and other AI tools for validation processes.
  • Excellent analytical, problem-solving, and communication skills.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.

Why Join Us

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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