Qualified Person, UK

Moderna

15h

About The Position

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 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 batches 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’ll be the key authority for certifying batches for release and be integral to Quality leadership at the Harwell site — directly influencing both compliance and continuous improvement across the Pharmaceutical Quality System.

Requirements

• 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 (QP), 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, including interpretation and application of EU GMP and associated MHRA guidance.
• Demonstrated, in-depth understanding of broader GMP 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.
• Patient-Centric Mindset: Acts consistently with the understanding that patient safety, product quality and supply reliability are the primary drivers of all QP decisions.
• Digital and Data-Driven: Comfortable working with electronic systems, data analytics and digital platforms to support decision making and batch certification activities.
• Strong Communicator and Collaborator: Able to communicate complex quality and regulatory concepts clearly, and work effectively across functions and external partners.
• Lean Thinker: Applies lean principles to simplify processes, reduce waste and improve the effectiveness of the quality system.
• Agile and Innovative: Able to adapt to evolving regulatory expectations, identify opportunities for improvement and drive innovative solutions within quality frameworks.
• Risk-Based Mindset: Uses structured Quality Risk Management (QRM) tools and principles to support robust, science-based decision making.
• Accountable and Solutions-Oriented: Takes ownership of commitments, demonstrates sound professional judgement and proactively delivers pragmatic, compliant solutions.

Responsibilities

• Acting as the named Qualified Person (QP) 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 responsibilities, ensuring it is fit for purpose.
• Escalating GMP or product quality concerns related to safety and efficacy to senior leadership.
• 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.
• Serving as the QP point of contact for Technical/Quality Agreement reviews and approvals.
• 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.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees