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Manager, Quality Control Operations
hace 2 semanas
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's 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 center 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. We 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 Do : Your key responsibilities will be: Lead and coordinate QC Operations functions including sample management, data management, equipment qualification, and digital system support. Serve as the QC Operations lead for Madrid's laboratory systems (e.g., LIMS, Chromeleon, LabX), acting as system owner or coordinator as assigned. Oversee activities related to QC sample management: receipt, tracking, distribution, storage, and disposal. Ensure robust lifecycle management of laboratory instruments and documentation in compliance with GMP and ALCOA+ principles. Manage equipment qualification programs, including protocol execution and change control. Drive QC data integrity through accurate, complete, and timely data governance across digital systems. Collaborate cross-functionally to implement digital tools, streamline data workflows, and improve transparency through dashboards and analytics. Support internal and external audits, inspections, and overall laboratory readiness. Your responsibilities will also include: Coach and set performance expectations within QC Operations while fostering continuous improvement. Champion the digital transformation of QC, including paperless workflows, system upgrades, and lab automation. Collaborate with QC Chemistry, Bioassay, Microbiology, and QA for coordinated testing operations. Support automation initiatives that improve data flow and laboratory efficiency, exploring the integration of AI tools to drive quality and operational insights. Author, review, and approve SOPs, protocols, validation documents, and quality records. Lead CAPA and Change Control processes and contribute to Quality Metrics reporting. Act as a strategic partner to Digital, Engineering, and IT teams in the alignment of lab systems with business needs. Ensure Moderna's safety and compliance standards are met within laboratory environments. The key Moderna Mindsets you'll need to succeed in the role: We 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. Experience : Minimum 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 Expertise: Knowledge 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 Skills : Excellent 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 benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation,
