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Manager, Quality Control Operations

hace 2 semanas


Madrid, España Moderna A tiempo completo

The RoleLa siguiente información tiene como objetivo proporcionar a los posibles candidatos una mejor comprensión de los requisitos para este puesto.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.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 within our international centre for analytical excellence in Madrid, a city known for its rich scientific heritage. This facility, the largest such centre outside the United States, exemplifies our commitment to solidifying our manufacturing network and advancing our promising mRNA product portfolio. We’re looking for talents who can contribute to our innovative research and development efforts.Manager, Quality Control Operations – MadridWe are looking for a Manager, Quality Control Operations to join our Madrid-based analytical excellence center. This role is a pivotal bridge between laboratory operations and digital innovation, ensuring streamlined QC processes across sample and data management, equipment qualification, and digital systems. As an individual contributor, you will lead the QC Operations group and drive digital transformation and operational compliance across laboratory systems. Your work will directly support the quality control of intermediates, drug substances, and drug products—ultimately contributing to the timely and accurate delivery of Moderna’s mRNA medicines. You’ll work in close partnership with QA, IT, and Automation teams to enhance system integration and right-first-time performance. With opportunities to engage in cutting-edge automation and generative AI solutions, this role offers a front-row seat in shaping the future of digitally enabled laboratories.Here’s What You’ll DoYour key responsibilities will beLead and coordinate QC Operations functions including sample management, data management, equipment qualification, and digital system supportServe as the QC Operations lead for Madrid’s laboratory systems (e.g., LIMS, Chromeleon, LabX), acting as system owner or coordinator as assignedOversee activities related to QC sample management: receipt, tracking, distribution, storage, and disposalEnsure robust lifecycle management of laboratory instruments and documentation in compliance with GMP and ALCOA+ principlesManage equipment qualification programs, including protocol execution and change controlDrive QC data integrity through accurate, complete, and timely data governance across digital systemsCollaborate cross-functionally to implement digital tools, streamline data workflows, and improve transparency through dashboards and analyticsSupport internal and external audits, inspections, and overall laboratory readinessYour responsibilities will also includeCoach and set performance expectations within QC Operations while fostering continuous improvementChampion the digital transformation of QC, including paperless workflows, system upgrades, and lab automationCollaborate with QC Chemistry, Bioassay, Microbiology, and QA for coordinated testing operationsSupport automation initiatives that improve data flow and laboratory efficiency, exploring the integration of AI tools to drive quality and operational insightsAuthor, review, and approve SOPs, protocols, validation documents, and quality recordsLead CAPA and Change Control processes and contribute to Quality Metrics reportingAct as a strategic partner to Digital, Engineering, and IT teams in the alignment of lab systems with business needsEnsure Moderna’s safety and compliance standards are met within laboratory environmentsThe key Moderna Mindsets you’ll need to succeed in the roleWe digitize everywhere possible using the power of code to maximize our impact on patients.This mindset is foundational to the role, which centers around digital system ownership and lab automation. You’ll champion digitalization to reduce manual processes and foster reliable, scalable, and compliant lab operations.We behave like owners. The solutions we’re building go beyond any job description.As a strategic individual contributor, you’ll take full ownership of systems and processes that support QC lab performance. Your proactive leadership will ensure efficiency, compliance, and adaptability in a dynamic, high-growth environment.Here’s What You’ll Need (Basic Qualifications)Education : Bachelor’s or Master’s degree in Chemistry, Biotechnology, Engineering, or a related scientific or technical discipline.ExperienceMinimum 7 years of experience in GMP Quality Control or Quality Operations, with 3+ years in leadership or supervisory role.Proven experience in laboratory systems management, equipment qualification, or digital transformation projects.Strong understanding of GxP, GMP, and Data Integrity principles.Technical ExpertiseKnowledge of QC laboratory processes, LIMS, instrument qualification, and data workflows.Experience with digital systems such as LabVantage, Chromeleon, Veeva, or similar platforms, standalone equipment.Familiarity with automation and paperless lab initiatives is a plus.Soft SkillsExcellent leadership, communication, and project management abilities.Strategic mindset with strong attention to detail and problem‑solving skills.Ability to drive cross‑functional initiatives and manage competing priorities in a fast‑paced environment.This position is site‑based, requiring you to be at Moderna’s site full‑time. This position is not eligible for remote work.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.Quality healthcare and insurance benefitsLifestyle Spending Accounts to create your own pathway to well‑beingFree premium access to fitness, nutrition, and mindfulness classesFamily planning and adoption benefitsGenerous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdownSavings and investmentsLocation‑specific perks and extrasThe benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.About ModernaSince 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 Place to Work in the U.S.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.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit /careers to learn more about our current opportunities.Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment.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 applyModerna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person’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.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. xsgfvud 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 #J-18808-Ljbffr