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Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients' lives worldwide. Moderna is solidifying its presence within our international business services hub in Warsaw, Poland, a city renowned for its rich scientific and technological heritage. This hub provides critical functions, meeting the growing demand of Moderna’s global business operations. We're inviting professionals from around the world to join our mission and contribute to the future of mRNA medicines. This individual contributor role is a pivotal part of Moderna’s Quality organization, responsible for administering and optimizing global digital Quality Systems with a focus on validation platforms. You will lead configuration, integration, and ongoing management of enterprise systems such as Kneat, Veeva, Tosca, and other internal solutions. You will ensure seamless operation, robust compliance, and forward-thinking enhancement of these systems. Working cross-functionally across Digital, Quality, and business teams, you will blend technical expertise with a deep understanding of Quality processes, supporting system validation, continuous improvement, and inspection readiness. This position will offer the opportunity to engage with next-generation automation and AI capabilities as part of Moderna’s drive toward intelligent Quality systems. You will play a key role in ensuring that Moderna’s validation and quality operations remain scalable, compliant, and digitally empowered.
Job Responsibility:
Serve as the technical lead and administrator for the electronic validation management system (Kneat)
Manage configuration, enhancement deployment, and role-based access control across systems
Deliver operational support and user enablement, including issue resolution, guidance, documentation, and training
Oversee metrics reporting and dashboard development to monitor system performance and compliance
Support validation and qualification activities across implementations and changes, in accordance with GxP and SDLC
Manage system data integrity and ensure seamless integration across quality and testing platforms
Administer additional Quality systems including Veeva QMS/DMS, testing tools (e.g., Tosca), and internal platforms
Drive automation and AI adoption in digital Quality systems to improve compliance and performance
Manage delivery of digital Quality initiatives with a focus on validation tools, including proactive risk management and adherence to timelines
Collaborate across cross-functional teams to implement and integrate quality and validation platforms effectively
Evaluate enhancement requests and apply continuous improvement methodology to optimize workflows and user experience
Support audit and inspection readiness by ensuring systems are compliant and documentation is complete and current
Contribute to broader strategic Quality and Digital initiatives by prioritizing tasks and maintaining clear communication with stakeholders
Adhere to all internal SOPs and relevant global GxP regulations, ensuring that systems remain aligned with regulatory expectations
Manage multiple concurrent priorities and deliverables while supporting enterprise goals
Requirements:
Bachelor's degree in science, technology, or a related discipline
7+ years of experience in Quality Systems implementation and maintenance in a regulated biotech or pharmaceutical environment
Minimum 4 years of experience with Kneat (configuration, administration, and support)
Solid understanding of system validation tools and SDLC methodologies
Proven ability to execute computer system validation (CSV) in compliance with industry standards
Awareness of trends and technologies in document and validation management systems
Proficiency in English (verbal and/or written) required due to global collaboration needs
Nice to have:
2+ years of hands-on experience with Veeva and Tosca configuration
Familiarity with project management tools and frameworks (e.g., Jira)
Experience with APIs, data reporting, and system integrations
Strong interpersonal and communication skills with the ability to influence across functions
Working knowledge of FDA, EU, and ICH regulations related to CSV and data integrity
A passion for making an impact in a high-growth, fast-paced organization that values being Bold, Relentless, Curious, and Collaborative
What we offer:
Best-in-class healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being with access to fitness, mindfulness, and mental health support
Family building benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future