Sr. Specialist, Sample Management

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. Reporting to the Manager of Quality Control Operations, you will take ownership of end-to-end QC Sample Management, helping ensure Chemistry, Microbiology and Bioassay samples move safely, accurately and efficiently across Moderna and its external manufacturing network. As an individual contributor and subject matter expert for Sample Management, you will connect QC laboratories, External QC, Regulatory, Operations, Manufacturing, Quality Assurance, Supply Chain and CMO partners, translating complex sample requirements into coordinated execution while maintaining rigorous cGMP standards. This is a highly hands-on opportunity to combine laboratory operations, quality systems, controlled-temperature unit management and digital innovation, including partnering with Digital colleagues to optimize LIMS and gaining exposure to Generative AI tools that can support the evolution of QC operations. Here's What You'll Do: Define, implement and maintain an end-to-end sample management process for QC Chemistry, Microbiology and Bioassay samples received internally from Moderna sites and from CMO sites. Serve as a key point of contact and subject matter expert for Sample Management, partnering cross-functionally with QC laboratories, External QC, Regulatory, Operations, Manufacturing, Quality Assurance, Supply Chain and CMO partners to align sample-related activities, priorities, requirements and timelines. Coordinate and facilitate the cross-functional resolution of sample management issues, ensuring appropriate communication, escalation and follow-up with relevant stakeholders. Monitor and ensure the safe and timely execution of daily sample processing activities and accurate completion of associated quality records. Author and revise SOPs, protocols and quality system records, including deviations, CAPAs and change controls. Create weekly sample management schedules and run periodic alignment meetings with internal stakeholders and external partners as required. Partner with the Digital team to expand and optimize the use of the LIMS system, while exploring opportunities to get closer to Generative AI tools and emerging digital capabilities that can further enhance QC workflows, knowledge and operational efficiency. Work closely with Quality Control laboratory teams to continuously improve the quality, compliance and efficiency of laboratory sample operations. Provide support to audit teams during internal and external audits. Perform general laboratory support activities as required, including housekeeping. Manage controlled-temperature units, including their maintenance and troubleshooting. Lead troubleshooting activities and provide guidance and support to the sample management process when compliance issues arise. Train colleagues, oversee team training assignments and help ensure compliance requirements remain current. Establish and maintain a safe laboratory working environment. Foster a positive and inclusive working culture that promotes collaboration, innovation and continuous improvement. Follow all relevant GxP regulations, guidelines and company policies to ensure compliance with regulatory and internal requirements. Execute tasks precisely as defined in internal guiding documents, including standard operating procedures and work instructions. Follow Good Documentation Practices and Data Integrity requirements, ensuring data, documentation and records are completed and maintained appropriately for business use and are available to support audits or inspections. Complete training within the assigned required learning plan according to defined timelines and prescribed requalification cadence. The key Moderna Mindsets you’ll need to succeed in the role: “We act with dynamic range, driving strategy and execution at the same time at every step.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Bring to the Table: Minimum: BA/BSc in a relevant scientific discipline At least 5 years in Quality Control in a cGMP organization. Strong 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. Proficiency in English (verbal and/or written) required due to global collaboration needs." undefined Our Working Model As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations. Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive 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 Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great