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 endeavor, contributing to a future where access to life-saving vaccines is a reality for all. In this pivotal role, reporting directly to the Site Quality Head, you will be responsible for ensuring that all products are manufactured, certified, and released in strict accordance with EU directive 2002/83/EC. As the Qualified Person (QP), you will bring your expert knowledge of biologics and sterile manufacturing to ensure the Pharmaceutical Quality System (PQS) is robust and fit for purpose. You will be named on the Manufacturer’s Authorisation from MHRA, playing a critical role in upholding the highest standards of product quality, safety, and efficacy. Here's What You’ll Do: Your key responsibilities will be: Being named as the Qualified Person on Moderna’s site licence(s). Ensuring that all products are manufactured and released in compliance with EU directive 2002/83/EC. Overseeing the release of biologically active intermediates and sterile products in line with cGMP, approved product descriptions, and regulatory filings. Providing leadership in Quality Systems and Compliance QRM principles across the site, ensuring alignment with evolving regulatory expectations. Maintaining oversight of the Quality Management System (QMS) as part of your operational responsibilities and escalating GMP concerns when necessary. Representing Quality at Management Review Forum meetings and reporting on critical issues. Leading self-inspections, external audits, and Quality Risk Assessments as required. Your responsibilities will also include: Delegating tasks to appropriately trained personnel or third parties and collaborating closely with the Quality Assurance team. Acting as the QP point of contact for QA agreements, and reviewing and approving major/critical deviations, change proposals, and other quality records with potential batch impact. Overseeing BMR and record reviews as part of the QP batch release process. Keeping abreast of new and emerging regulatory guidance, ensuring company policies and procedures remain compliant. Providing Quality oversight for commissioning, qualification, and validation initiatives, including complex GMP facilities and critical utility projects. Collaborating cross-functionally to foster a strong Quality Culture and continuous improvement mindset. The key Moderna Mindsets you’ll need to succeed in the role: We act with dynamic range : This role requires the ability to drive both strategy and execution simultaneously, ensuring that quality initiatives are implemented effectively at every level. We prioritize the platform : Your focus will be on maintaining and enhancing the overarching quality framework, ensuring that it supports Moderna’s broader goals rather than just individual solutions. Here’s What You’ll Bring to the Table: Life Science degree and / or post-graduate. 10 – 15 years of international quality experience in the biotechnology or pharmaceutical industry. Must meet QP eligibility requirements combined with relevant biologics and steriles knowledge to be named on Manufacturer’s Authorisation from MHRA. Meets requirements of continuing professional development required to maintain QP status. Experience working in a GMP pharmaceutical / sterile / biological production environments. Expert knowledge of Quality Management systems. Extensive knowledge, interpretation and application of quality management within a GxP environment for early phase clinical trials & commercial products. Demonstrates an in-depth understanding and proven application of the broader GMP principles, concepts, industry best practices, standards and trends. Experienced Pharmaceutical Auditor. Experience with hosting and participating in regulatory inspections. Experience of influencing/leading others and implementing change. This role is expected to be in office 70% of the time with flexibility to work from home up to 30%. Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: 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, and a discretionary year-end shutdown Educational resources 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 employment opportunity 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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations 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 leavesandaccommodationsmodernatx.com. -