Sr. Specialist, Quality Control

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its international centre for analytical excellence in Madrid, the largest of its kind outside the United States. The site supports our global manufacturing network and advancing mRNA portfolio. We welcome talent ready to drive innovative research and development. Moderna is seeking a highly skilled Quality Control specialist to help shape the future of chromatographic data management across our global QC laboratory network. As a subject matter expert in Thermo Scientific Chromeleon Chromatography Data System (CDS), you will combine advanced hands-on expertise in HPLC/UPLC workflows, analytical method configuration, data processing and complex report development with the opportunity to drive global standardization, scientific accuracy and cGMP compliance. Working at the intersection of analytical science, Quality and Digital innovation, you will play a critical role in developing reliable, efficient and inspection-ready chromatography workflows that strengthen data integrity, accelerate laboratory performance and support the delivery of Moderna's innovative mRNA medicines. Here's What You'll Do: Serve as a global subject matter expert for Chromeleon CDS: Provide advanced technical expertise in Thermo Scientific Chromeleon, supporting QC laboratories across Moderna's global network. Act as a trusted specialist in chromatography workflows, system functionality, HPLC/UPLC method configuration, chromatographic data acquisition, processing, integration, calculations and reporting, ensuring scientifically sound, standardized and compliant system use. Design, configure and maintain standardized chromatography workflows: Develop, build, review and maintain robust Chromeleon configurations supporting HPLC analytical workflows, including instrument methods, processing methods, analytical sequences, electronic workflows and report templates. Translate approved analytical method requirements into reliable CDS configurations that enable consistent analytical execution, data processing, calculations, review and reporting across multiple QC laboratories. Develop and troubleshoot complex Chromeleon report templates: Create, configure and optimize sophisticated reporting solutions incorporating calculations, variables, custom fields, tables, chromatograms, system suitability results, specifications and other critical report elements. Ensure that report outputs accurately reflect approved analytical methodologies, support effective QC data review and minimize manual intervention while maintaining scientific accuracy and regulatory compliance. Provide advanced expertise in chromatographic data processing and integration: Configure and optimize Chromeleon processing methods, peak integration parameters, calculation logic and standardized integration approaches. Apply deep practical knowledge of chromatographic principles, HPLC/UPLC workflows, system suitability and analytical data interpretation to ensure consistent, scientifically justified and reproducible results. Lead technical troubleshooting and resolution of complex CDS issues: Investigate and resolve challenging technical issues involving chromatographic data acquisition, processing, peak integration, calculations, report generation, sequence execution, instrument connectivity and user workflows. Partner with analytical method owners, laboratory analysts and technical SMEs to diagnose unexpected template behavior, calculation discrepancies, processing anomalies and reporting defects, driving issues through to effective resolution. Ensure technical accuracy and scientific integrity of Chromeleon configurations: Perform detailed technical reviews of instrument methods, processing methods, report templates and associated workflows to verify accuracy, consistency, usability and alignment with approved analytical methods and QC requirements. Identify potential configuration weaknesses, calculation errors and reporting inconsistencies, implementing appropriate improvements to support reliable analytical results and compliant data review. Drive global standardization and continuous improvement: Collaborate with QC laboratories and analytical method owners across Moderna sites to harmonize Chromeleon templates, reporting standards and chromatography workflows. Assess existing configurations to identify opportunities to reduce manual transcription, simplify analytical execution and review, improve data integrity and increase operational efficiency while maintaining the flexibility required for different analytical methods. Support qualification, validation and controlled deployment: Provide technical expertise throughout the qualification, validation, change control and implementation of new or revised Chromeleon methods, templates, reports and configurations. Ensure changes are appropriately assessed, tested, documented and deployed within a controlled cGMP environment, maintaining alignment with approved analytical requirements, internal procedures and applicable regulatory expectations. Collaborate with Digital teams on CDS lifecycle management: Work closely with Digital, system administration and laboratory stakeholders to support Chromeleon system configuration, upgrades, testing, technical issue resolution and implementation of enhancements. Contribute specialist QC knowledge to system lifecycle activities, helping ensure that CDS functionality continues to meet evolving analytical, operational and compliance requirements. Strengthen cGMP compliance and chromatographic data integrity: Ensure that Chromeleon configurations, electronic workflows and associated QC processes comply with applicable current Good Manufacturing Practice (cGMP) requirements, data integrity expectations, internal Quality procedures and regulatory standards. Support accurate, traceable and reliable electronic data processing and reporting, reinforcing inspection readiness and confidence in analytical results. Support Quality investigations and change management: Provide technical input into investigations, deviations, corrective and preventive actions (CAPAs) and change controls involving Chromeleon functionality, HPLC data workflows, method and template configurations, calculations or reporting. Apply structured problem-solving and scientific judgment to identify root causes, assess potential impacts and implement sustainable corrective solutions. Develop technical documentation and strengthen laboratory capabilities: Author, review and revise Standard Operating Procedures (SOPs), work instructions, technical standards, training materials and supporting documentation related to Chromeleon CDS, chromatography template configuration, data review and troubleshooting. Provide hands-on technical guidance, coaching and software training to QC analysts and reviewers, strengthening their understanding of HPLC workflows, chromatographic integration, data processing and report interpretation. Advance digital innovation within global QC operations: Identify opportunities to leverage automation, digital technologies and emerging Generative AI-enabled tools to improve technical knowledge sharing, documentation efficiency, troubleshooting workflows and analytical process standardization. Partner with relevant Digital and Quality stakeholders to explore these capabilities within appropriate validation, data integrity, information security and cGMP compliance