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's mission is to establish a leading-edge research, development, and manufacturing facility at Harwell, as part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic, NHS and government partners across the UK. We're looking for global experts eager to join us in this endeavour, contributing to a future where access to life-saving vaccines is a reality for all. As Manager, Quality Assurance for Quality Control (QA for QC), you will provide comprehensive quality oversight for QC activities at our UK manufacturing sites—primarily the Harwell facility. You’ll serve as a critical member of the Quality Assurance function, ensuring that all QC operations align with cGMP, global regulations, and internal Moderna standards. This is an opportunity to help shape a strong quality culture, support complex lab operations, and contribute to Moderna’s mission by enabling a reliable and compliant analytical framework across our expanding global network. You’ll also play a central role in embedding inspection readiness into daily operations and have the chance to work with international sites, including Norwood, Madrid, and key external testing partners. As part of Moderna’s cutting-edge work in mRNA manufacturing, this role also provides opportunities to engage with emerging technologies, including digital tools and platforms that accelerate compliance and decision-making. Here’s What You’ll Do: Your key responsibilities will be: Provide strategic and operational quality oversight to QC laboratories at Harwell, aligned with Moderna’s global quality framework. Ensure QC methods, processes, and SOPs are scientifically robust, validated, and aligned with regulatory expectations (e.g., ICH Q2 (R2), USP/Ph. Eur.). Lead the QA review and approval of laboratory-related documentation, such as SOPs, analytical reports, Annual Product Quality Reviews, and trend analyses. Oversee qualification, validation, and transfer of analytical methods to internal and external labs, ensuring lifecycle management and scientific integrity. Support continuous GMP compliance by ensuring adherence to Good Documentation Practices and Data Integrity standards. Oversee and support OOS/OOT investigations to ensure they are prompt, unbiased, scientifically justified, and concluded with effective CAPAs. Conduct on-the-floor QA oversight via lab walkthroughs, data reviews, and staff coaching. Your responsibilities will also include: Lead inspection readiness efforts and actively participate in hosting MHRA, FDA, and other regulatory inspections. Monitor training, qualification, and competency records for QC personnel to ensure compliance. Perform risk-based QA decision-making using ICH Q9 principles. Oversee quality aspects of external/contract laboratories, including qualification and performance monitoring. Execute trend analysis of QC data and verify CAPA effectiveness. Maintain alignment with other Moderna labs (Norwood, Madrid, Resilience sites) and ensure harmonization where possible. Foster an inclusive and quality-focused team culture that values collaboration and continuous improvement. Ensure task execution follows internal SOPs and global policies precisely and compliantly. Participate in on-call rotations or shift coverage when required to support 24/7 manufacturing operations. Additional duties as assigned in alignment with evolving site priorities. 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 requires you to take full ownership of QC oversight—supporting lab staff, influencing documentation practices, and escalating critical issues—all with a proactive and leadership-driven mindset. You will represent QA in cross-functional environments and be seen as a trusted authority. We digitize everywhere possible using the power of code to maximize our impact on patients. With Moderna's strong focus on innovation, this role offers opportunities to adopt digital quality systems and analytics platforms to enhance compliance and drive more agile decision-making in QC oversight. Here’s What You’ll Need (Basic Qualifications): Education: Bachelor’s Degree in a scientific field. Experience: 8 – 10+ years of Biopharmaceutical / Pharmaceutical Industry within Quality. As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check. Here’s What You’ll Bring to the Table (Preferred Qualifications): Strong working knowledge of cGMP regulations, ISO standards, and other relevant regulatory guidance document. Experience with regulatory inspections as a Subject Matter Expert (SME), including direct interactions with worldwide health authorities. Demonstrated experience in analytical or microbiological method validation. Experience with OOS/OOT investigation management, risk management, and digital quality systems. Strong leadership skills with ability to develop, mentor, and motivate diverse teams. Excellent project management, organizational, and communication skills. Experience interacting with regulatory authorities during regulatory inspections. Demonstrated ability making risk-based decisions. 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, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments 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 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. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home