Associate Director, Computer Software Assurance and Validation

8 hours ago

Kingston, New Jersey, United States Genmab Full time
About the Role

Genmab is seeking an experienced Associate Director, Computer Software Assurance and Validation to join our team. As a key member of our IT and Digital department, you will be responsible for elevating our validation processes using advanced technologies such as Generative AI (GenAI), 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.
  • Utilize unscripted testing and risk-based validation methods to ensure compliance and efficiency.
  • Perform risk assessments and develop mitigation strategies to address potential validation issues.
  • Implement and maintain automated validation solutions to enhance process efficiency.
  • Integrate automation into existing validation workflows, ensuring compliance with regulatory requirements.
  • Apply the FDA's new CSA guidelines to reduce documentation burdens while maintaining product quality and safety.
  • Conduct rigorous and ongoing data evaluation to ensure compliance without overdocumentation.
  • Compile and analyze validation data using advanced data analytics and machine learning techniques.
  • Prepare comprehensive validation reports and make recommendations for process improvements.
  • Maintain thorough validation documentation and ensure it is readily accessible for audits and inspections.
  • Collaborate with Data Science, AI, and business functions to promote a product mindset.
  • Enable product teams to recognize and manage interdependencies between products and platforms.
  • Conduct workshops and training sessions to enhance the team's understanding of advanced validation techniques.
  • Guide and mentor team members in best practices for validation and qualification.
  • Manage a team of BPO consultants on ongoing initiatives and ensure standardization and QC across deliverables.
  • Establish a CoE to develop the practice further along with industry evolution.
  • Continuously assess opportunities to drive procedural improvement and enhancement.
  • Stay updated on industry best practices and regulatory changes related to validation and CSA.
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.
  • Experienced in managing GxP systems, DevSecOps, Agile methodologies, operating within the Atlassian suite, and a product-based delivery model.
  • Proficiency in utilizing GenAI and other AI tools for validation processes.
  • Strong understanding of unscripted testing, risk-based validation, and CSA methodologies.
  • Experience with automation technologies and integrating them into validation workflows.
  • Excellent analytical, problem-solving, and communication 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.
  • Bachelor's or master's degree in Engineering, Computer Science, or a related field.
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.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

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