Associate Director, Computer Software Assurance and Validation

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

We are seeking an experienced Computer Software Assurance/Validation leader to elevate 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.

This position will be reporting to the VP of Global R&D Digital Products within the IT & Digital department.

This person will be based out of Princeton, NJ and will be onsite 60% of the time.

Key Responsibilities:

Validation Strategy Development:

• 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

Unscripted Testing and Risk-Based Validation:

• 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.

Automation in Validation:

• Implement and maintain automated validation solutions to enhance process efficiency.
• Integrate automation into existing validation workflows, ensuring compliance with regulatory requirements.

Computer Software Assurance (CSA):

• 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.

Data Analysis and Reporting:

• 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.

Interdepartmental Collaboration:

• 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.

Training and Mentorship:

• 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

Continuous Improvement:

• Continuously assess opportunities to drive procedural improvement and enhancement.
• Stay updated on industry best practices and regulatory changes related to validation and CSA.

Qualifications and Skills:

• Experience:

  • 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.

• Skills:

  • 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.

• 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.

Education:

• Bachelor’s or master’s degree in Engineering, Computer Science, or a related field.
• Additional certifications in validation and quality assurance are a plus.

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.

For US based candidates, the proposed salary band for this position is as follows:

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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 (KYSO™) 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. 

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. 

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.