Senior Specialist, Quality Control, Laboratory Systems

hace 6 días


Madrid, España ModernaTX A tiempo completo

The Role Joining Moderna offers the unique opportunity to be part of a pioneering team thats 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 in Madrid, a city that thrives on creativity and innovation. As a crucial part of our commercial operations outside the United States, our Madrid office focuses on delivering our groundbreaking products to the Spanish market. We're seeking professionals who are ready to contribute to our mission and shape the future of mRNA medicines in Spain. This is a site-based individual contributor role in Madrid focused on supporting all Digital systems in Moderna’s Quality Control laboratories. Acting as a bridge between QC and Digital teams you'll enable seamless operation and compliance of laboratory systems while configuring and deploying critical digital platforms that support analytical excellence. This role will play a hands‑on part in system configuration, training documentation and ensuring adherence to global regulatory standards. It’s a high‑impact position at the convergence of QC operations, Digital innovation and compliance, offering the opportunity to work closely with cutting‑edge tools including Generative AI platforms evolving within Moderna’s digital ecosystem. What You'll Do Your key responsibilities will be: Provide ongoing Digital support for all laboratory computer systems in QC. Collaborate with Digital and QC teams to install, configure and maintain standalone lab systems. Act as the primary liaison between Digital and QC to support business and operational needs. Own and manage quality system records such as deviations, CAPAs and change controls related to QC software systems. Support method troubleshooting and remediation initiatives and system optimization projects in cross‑functional teams. Author or revise SOPs related to equipment software and QC methodologies. Deliver training to QC personnel on lab system software. Participate in cross‑functional process improvement projects that enhance QC digital infrastructure. Ensure documentation is completed in accordance with cGMP and regulatory requirements. Follow all GxP guidelines, internal SOPs and Good Documentation Practices to maintain data integrity and audit readiness. Mindsets and Skills We digitize everywhere possible using the power of code to maximize our impact on patients. This mindset is central to the role as you will help implement and support digital systems critical to QC operations. Your ability to leverage digital tools to optimize data integrity and laboratory efficiency will directly impact the pace and quality of our scientific outputs. We obsess over learning. We don’t have to be the smartest; we have to learn the fastest. With rapidly evolving digital platforms and regulatory expectations your ability to continuously learn and adapt will be essential, especially as Moderna expands its use of Generative AI and innovative digital tools in QC environments. What You'll Bring to the Table BS in a relevant scientific discipline (Science, Engineering and Business). 5 years experience in quality control laboratory of a pharmaceutical company is preferred. Working experience in a GMP environment. Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations. 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. Site-based requirement: full‑time at Moderna site; no remote work. Benefits Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well‑being Free premium access to fitness, nutrition and mindfulness classes Family planning and adoption benefits Generous paid time off including vacation,



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