Senior Specialist, Sample Management

hace 5 días


Madrid, España Moderna A tiempo completo

Senior Specialist, Sample Management Location: Moderna Madrid, Community of Madrid, Spain The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. This highly cross‑functional role will contribute significantly to Moderna’s QC capabilities at its analytical excellence center in Madrid. The Quality Control Senior Specialist will define and execute the end‑to‑end sample management processes for Chemistry, Microbiology, Bioassay, and Raw Materials. Reporting to the Manager of QC Operations, the successful candidate will support daily sample processing, ensure compliance with GMP standards, and drive continuous improvement initiatives. Your key responsibilities will include Define, implement, and maintain comprehensive sample management systems for QC Chemistry, Microbiology, Bioassay, and Raw Materials. Lead daily sample processing operations and ensure timely, accurate, and GMP‑compliant execution. Create weekly schedules and lead alignment meetings with internal stakeholders and external laboratories/CMOs. Partner with the Digital team to optimize LIMS usage for improved sample tracking and data integrity. Monitor CTU (Controlled Temperature Unit) performance and manage troubleshooting and maintenance as required. Additional responsibilities will also include Author and revise SOPs, protocols, deviations, CAPAs, and change controls. Train the QC team on sample management protocols and oversee training compliance. Execute general laboratory activities including housekeeping and audit support. Drive continuous improvement across QC workflows and documentation practices. Uphold data integrity, Good Documentation Practices, and safety standards. Foster a collaborative, inclusive, and innovation‑driven lab culture. Moderna Mindsets We digitize everywhere possible using the power of code to maximize our impact on patients. The role will partner with Digital and QC Operations teams to help optimize the LIMS system, and may explore Generative AI tools that improve quality, speed, and data traceability. We behave like owners. The solutions we’re building go beyond any job description. The role requires proactive ownership of the sample management lifecycle, leading with accountability, compliance, and a problem‑solving mindset in close coordination with global and local QC teams, CMOs, and digital systems integration. Required Qualifications Minimum: BA/BSc in a relevant scientific discipline. Minimum: 5 years in Quality Control in a cGMP organization. Strong working experience in a GMP environment. Working knowledge of relevant 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 full‑time presence at Moderna’s site and is not eligible for remote work. Benefits Quality healthcare and insurance benefits. Lifestyle spending accounts. Free premium access to fitness, nutrition, and mindfulness classes. Family planning and adoption benefits. Generous paid time off, including vacation,



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