The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you will 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.
Key Responsibilities
* Act as the named Qualified Person on Moderna’s site licence(s).
* Certify and authorise batch releases in full compliance with The Human Medicines Regulations 2012, EU GMP (Annex 16, and where applicable, Annex 13), and MHRA guidance.
* Ensure sterile drug product batches meet cGMP, approved specifications, and the conditions of the Marketing or Clinical Trial Authorisation.
* Maintain oversight of the PQS as it pertains to QP responsibilities, ensuring it is fit for purpose.
* Escalate GMP or product quality concerns related to safety and efficacy to senior leadership.
Additional Responsibilities
* Participate as a member of the site and country Quality teams, promoting a strong quality culture and QRM principles.
* Attend and report at the Quality Management Review Forum.
* Oversee delegated activities and ensure proper training of personnel or third parties.
* Lead or participate in self‑inspections, external audits, and Quality Risk Assessments.
* Serve as the QP point of contact for Technical/Quality Agreement reviews and approvals.
* Review and approve deviations, OOS, OOT, excursions, CAPAs, risk assessments, and other batch‑impacting quality records.
* Review and approve electronic batch records (eBR) and associated documentation for batch release.
* Monitor emerging regulatory guidance and ensure continued compliance through internal assessments.
* Provide Quality oversight for validation and qualification of GMP facilities, utilities, and equipment.
* Oversee product technology transfers from a Quality perspective.
* Collaborate cross‑functionally to drive Quality culture and embed a continuous improvement mindset.
Mindsets Required
* We behave like owners. As the QP, your accountability for product release and site compliance means acting with authority, responsibility, and ownership across every part of the Quality function.
* We question convention because proven models don’t always fuel the future. In a role so deeply tied to regulation, you’ll also be expected to drive innovation and adaptability – shaping quality systems that serve both cutting‑edge science and evolving compliance landscapes.
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, 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 or biological manufacturing environments.
* Expert knowledge of Pharmaceutical Quality Management Systems and 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.
Pay & 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.
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
Equal Opportunity & Accommodations
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. 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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