Qualified Person, UK

Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionising medicine through mRNA technology, with a diverse pipeline of development programmes across various diseases. As an employee, you will be part of a continually growing organisation, 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.

As a Qualified Person (QP), reporting to the Site Quality Head, you will play a critical role in ensuring the release of Moderna’s innovative mRNA-based drug products aligns with the strictest regulatory standards. This pivotal position sits at the core of our UK manufacturing operations, ensuring all certified products comply with The Human Medicines Regulations 2012 and EU GMP, including Annex 16. You will bring advanced knowledge of biologics and sterile products and meet the eligibility criteria to be named on the Manufacturer’s Authorisation from the MHRA. You will be the key authority for certifying batches for release and be integral to Quality at the Harwell site — directly influencing both compliance and continuous improvement across the Pharmaceutical Quality System.

Here’s What You’ll Do

• Acting as the named Qualified Person on Moderna’s site licence(s).
• Certifying and authorising batch releases in full compliance with The Human Medicines Regulations 2012, EU GMP (Annex 16, and where applicable, Annex 13), and MHRA guidance.
• Ensuring sterile drug product batches meet cGMP, approved specifications, and the conditions of the Marketing or Clinical Trial Authorisation.
• Maintaining oversight of the PQS as it pertains to QP divergences, ensuring it is fit for purpose.
• Escalating quality concerns related to safety and efficacy to senior leadership.

Your responsibilities will also include:

• Participating as a member of the site and country Quality teams, promoting strong quality culture and QRM principles.
• Attending and reporting at the Quality Management Review Forum.
• Overseeing delegated activities and ensuring proper training of personnel or third parties.
• Leading or participating in self-inspections, external audits, and Quality Risk Assessments.
• Reviewing and approving deviations, OOS, OOT, excursions, CAPAs, risk assessments, and other batch-impacting quality records.
• Reviewing and approving electronic batch records (eBR) and associated documentation for batch release.
• Monitoring emerging regulatory guidance and ensuring continued compliance through internal assessments.
• Providing quality oversight for validation and qualification of GMP facilities, utilities, and equipment.
• Overseeing product technology transfers from a quality perspective.
• Collaborating cross-functionally to drive quality culture and embed a continuous improvement mindset.

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.
• We question convention because proven models don’t always fuel the future.

Here’s What You’ll Bring to the Table

• A life science degree and/or relevant postgraduate qualification, with a minimum of 10 years’ experience in quality roles within the biotechnology and/or pharmaceutical industry.
• Eligibility to act as a qualified person, with demonstrable knowledge of biologics and sterile manufacturing sufficient to be named on the site’s licences issued by the MHRA.
• Commitment to maintaining QP status through ongoing Continuing Professional Development.
• Experience working in GMP-regulated pharmaceutical/biological manufacturing environments.
• Expert knowledge of Pharmaceutical Quality Management Systems, including their application across the product lifecycle.
• Extensive understanding of GxP requirements for both early-phase clinical trial materials and commercial products.
• Demonstrated, in-depth understanding of broader GMD principles, industry standards, and current trends shaping the regulatory landscape.
• Experience as a qualified pharmaceutical auditor (internal and/or external).
• Proven experience hosting and participating in regulatory inspections (e.g., MHRA, FDA, EMA).
• Demonstrated ability to influence cross-functional teams, provide leadership, and drive organisational change.

Pay & Benefits

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.

• Best-in-class healthcare, plus voluntary benefit programs to support your unique needs.
• A holistic approach to well-being with access to fitness, mindfulness, and mental health support.
• Family building benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investments to help you plan for the future.
• 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.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to apply!