Specialist, Quality Control, Data Management

The Role: 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 footprint within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such center outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We're looking for talents who can contribute to our innovative research and development efforts. In this role, the Quality Control Compliance Specialist will act as a cornerstone in ensuring the integrity and compliance of QC documentation and data reporting within Moderna’s Madrid site. This individual contributor role will support the broader QC function through accurate authoring and/or approval of Certificates of Analysis (COAs), stability data packages, and adherence to good documentation practices. The Specialist will ensure deviations are handled timely, corrective actions are effective, and all compliance-related expectations are met to support inspection readiness. Collaboration will span across QC, QA, Digital Lab Systems, AS&T, and MS&T teams to deliver high standards in data integrity and compliance. The role offers unique exposure to digital laboratory systems and proximity to emerging generative AI tools for documentation and data review workflows. A strong attention to detail, compliance mindset, and cross-functional agility are critical for success. Here's What You’ll Do: Your key responsibilities will be: Author and/or approve QC Certificates of Analysis and stability data packages, ensuring full compliance with protocols, specifications, and standards. Perform thorough compliance reviews of QC data reports, verifying all associated laboratory documentation has been properly reviewed and approved. Ensure timely closure of all laboratory events, OOX investigations, and deviations prior to finalizing COAs or data reports. Collaborate with the QC Lab Systems team to ensure alignment and digital compliance within QC reporting systems. Your responsibilities will also include: Conduct and/or participate in investigations for QC deviations, ensuring progression adheres to procedural timelines. Implement or support effective CAPAs for lab events and deviations where assigned. Contribute to stakeholder assessments for change controls involving QC. Identify areas for continuous improvement and propose or help implement compliant solutions across QC processes. Support various inspection readiness activities to uphold audit preparedness. Accept and deliver on special assignments as needed, in accordance with procedural timelines and GxP compliance expectations. The key Moderna Mindsets you’ll need to succeed in the role: We behave like owners. The solutions we’re building go beyond any job description. This role demands proactive ownership of QC documentation, data integrity, and lab compliance. You’ll take initiative not only in assigned tasks but in identifying and solving broader compliance challenges that impact the team and site readiness. We digitize everywhere possible using the power of code to maximize our impact on patients. Your work will intersect with digital QC systems and offer increasing opportunities to engage with cutting-edge digital tools—including AI-powered systems—to ensure data consistency and process optimization in a modern laboratory environment. Here’s What You’ll Need (Basic Qualifications) BS in a relevant scientific discipline (Science, Engineering and Business) Working experience: +3 years ‘experience in quality control laboratory of a pharmaceutical company. Working experience in a GMP environment. Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment. This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work. Proficiency in English (verbal and/or written) required due to global collaboration needs. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. 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,