Senior Specialist, Quality Control, Sample Management

If you’re interested in this role, please apply in English and include an English version of your Resume/CV.<p> </p><p><b>The Role:</b></p><p>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.</p><p></p><p>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.</p><p></p><p>In this role, you will own and evolve the end-to-end sample management lifecycle across multiple QC disciplines, ensuring precision, compliance, and operational excellence.</p><p></p><p>You will operate at the intersection of laboratory execution, quality systems, and digital innovation, enabling scalable and efficient sample workflows.</p><p></p><p>This is a highly hands-on position where your ability to drive structure, solve complex issues, and collaborate cross-functionally will directly impact product quality and patient outcomes.</p><p></p><p><b>Here&#39;s What You&#39;ll Do:</b></p><ul><li><p>Define, implement, and maintain an end-to-end sample management process for QC Chemistry, Microbiology, Bioassay, and Raw Materials samples received internally from Moderna sites and from CMO laboratories.</p></li><li><p>Monitor and ensure the safe and timely execution of daily sample processing activities, ensuring accurate completion of all associated quality records in line with regulatory expectations.</p></li><li><p>Author and revise SOPs, protocols, and quality system records, including deviations, CAPAs, and change controls, ensuring full compliance with GxP standards.</p></li><li><p>Create and manage weekly sample management schedules, while leading periodic alignment meetings with internal stakeholders and external partners to ensure seamless coordination.</p></li><li><p>Partner closely with Digital teams to expand and optimize the use of LIMS systems, leveraging digital tools and opportunities—including exposure to Generative AI capabilities—to enhance data integrity, traceability, and operational efficiency.</p></li><li><p>Collaborate with Quality Control laboratory teams to continuously improve the quality, compliance, and efficiency of laboratory sample operations.</p></li><li><p>Support internal and external audit activities, ensuring inspection readiness and providing clear, compliant documentation and responses.</p></li><li><p>Perform general laboratory support activities as required, including housekeeping, to maintain operational readiness.</p></li><li><p>Oversee controlled temperature unit (CTU) management, including maintenance and troubleshooting, ensuring sample integrity is preserved at all times.</p></li><li><p>Lead troubleshooting efforts and provide guidance on sample management processes, particularly in resolving compliance-related issues.</p></li><li><p>Train personnel and oversee training assignments, ensuring all compliance requirements and qualifications remain current and aligned with defined learning plans and requalification cadence.</p></li><li><p>Establish and maintain a safe laboratory working environment, reinforcing a strong culture of safety and accountability.</p></li><li><p>Foster a positive, inclusive work culture that promotes collaboration, innovation, and continuous improvement across teams.</p></li><li><p>Ensure strict adherence to all relevant GxP regulations, guidelines, and company policies, maintaining full compliance with regulatory and internal requirements.</p></li><li><p>Execute all tasks precisely as defined in internal documentation, including SOPs and work instructions.</p></li><li><p>Apply Good Documentation Practices and Data Integrity principles to ensure all data, documentation, and records are accurate, complete, and audit-ready.</p></li><li><p>Complete all required training within defined timelines and maintain compliance with ongoing qualification requirements.</p></li></ul><p></p><p><b>The key Moderna Mindsets you’ll need to succeed in the role:</b></p><ul><li><p><b>“We digitize everywhere possible using the power of code to maximize our impact on patients.” </b></p></li><li><p><b>“We obsess over learning. We don’t have to be the smartest we have to learn the fastest.”</b></p></li></ul><p></p><p><b>Here’s What You’ll Need (Basic Qualifications)</b> </p><ul><li><p>Education: Minimum: BA/BSc in a relevant scientific discipline</p></li><li><p>Working Experience: Minimum: 5 years in Quality Control in a cGMP organization.</p></li><li><p>Strong working experience in a GMP environment.</p></li><li><p>Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.</p></li><li><p>Ability to collaborate effectively in a dynamic, cross-functional matrix environment.</p></li><li><p>Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.</p></li><li><p>Proficiency in English (verbal and/or written) required due to global collaboration needs.</p></li></ul><p></p><p><b>Pay &amp; Benefits</b></p><p></p><p><b>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.</b></p><ul><li><p>Best-in-class healthcare, plus voluntary benefit programs to support your unique needs</p></li><li><p>A holistic approach to well-being with access to fitness, mindfulness, and mental health support</p></li><li><p>Family building benefits, including fertility, adoption, and surrogacy support</p></li><li><p>Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown</p></li><li><p>Savings and investments to help you plan for the future</p></li><li><p>Location-specific perks and extras</p><p></p></li></ul><p></p><p>The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.</p><p></p><p><b>About Moderna</b></p><p>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.  </p><p></p><p>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. </p><p></p><p>We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. </p><p></p><p>As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. </p><p><br />If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit <a target="_blank" href="https://www.modernatx.com/en-US/careers/life-at-moderna">modernatx.com/careers</a> to learn more about our current opportunities. </p><p></p><p>Moderna is a smoke-free, alcohol-free, and drug-free work environment. </p><p></p><p>Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! </p><p></p><p>Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person&#39;s race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. </p><p></p><p>We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. </p><p></p><p>Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at <a target="_blank" href="mailto:leavesandaccommodations&#64;modernatx.com%22%20\o%20%22mailto:leavesandaccommodations&#64;modernatx.com%22%20\t%20%22_blank">leavesandaccommodations&#64;modernatx.com</a>. </p><p style="text-align:inherit">-</p>