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.
In this role, the Quality Control Compliance Specialist will act as a cornerstone in ensuring the integrity and compliance of QC documentation and data reporting within Moderna’s Madrid site. This individual contributor role will support the broader QC function through accurate authoring and/or approval of Certificates of Analysis (COAs), stability data packages, and adherence to good documentation practices. The Specialist will ensure deviations are handled timely, corrective actions are effective, and all compliance-related expectations are met to support inspection readiness. Collaboration will span across QC, QA, Digital Lab Systems, AS&T, and MS&T teams to deliver high standards in data integrity and compliance. The role offers unique exposure to digital laboratory systems and proximity to emerging generative AI tools for documentation and data review workflows. A strong attention to detail, compliance mindset, and cross-functional agility are critical for success.
Here's What You’ll Do:
Your key responsibilities will be:
Author and/or approve QC Certificates of Analysis and stability data packages, ensuring full compliance with protocols, specifications, and standards.
Perform thorough compliance reviews of QC data reports, verifying all associated laboratory documentation has been properly reviewed and approved.
Ensure timely closure of all laboratory events, OOX investigations, and deviations prior to finalizing COAs or data reports.
Collaborate with the QC Lab Systems team to ensure alignment and digital compliance within QC reporting systems.
Your responsibilities will also include:
Conduct and/or participate in investigations for QC deviations, ensuring progression adheres to procedural timelines.
Implement or support effective CAPAs for lab events and deviations where assigned.
Contribute to stakeholder assessments for change controls involving QC.
Identify areas for continuous improvement and propose or help implement compliant solutions across QC processes.
Support various inspection readiness activities to uphold audit preparedness.
Accept and deliver on special assignments as needed, in accordance with procedural timelines and GxP compliance expectations.
The key Moderna Mindsets you’ll need to succeed in the role:
We behave like owners. The solutions we’re building go beyond any job description.
This role demands proactive ownership of QC documentation, data integrity, and lab compliance. You’ll take initiative not only in assigned tasks but in identifying and solving broader compliance challenges that impact the team and site readiness.
We digitize everywhere possible using the power of code to maximize our impact on patients.
Your work will intersect with digital QC systems and offer increasing opportunities to engage with cutting-edge digital tools—including AI-powered systems—to ensure data consistency and process optimization in a modern laboratory environment.
Here’s What You’ll Need (Basic Qualifications)
BS in a relevant scientific discipline (Science, Engineering and Business)
Working experience: +3 years ‘experience in quality control laboratory of a pharmaceutical company.
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.
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.
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 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 modernatx.com/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 apply!
Moderna 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.
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 leavesandaccommodations@modernatx.com.
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