Qualified Person, UK

Moderna Therapeutics; Oxford; On-site; GBP 60,000 - 80,000; Full time

Job summary

A pioneering biotechnology firm in the UK is looking for a Qualified Person to ensure the release of mRNA-based drug products comply with regulatory standards. The role involves certifying batch releases, overseeing quality systems, and participating in audits. Candidates must have a Life Science degree and minimum 10 years of experience in quality roles. This position offers competitive salary and comprehensive benefits focusing on well-being and professional development.

Benefits

Best-in-class healthcare

Generous paid time off

Family building benefits

Qualifications

• Minimum of 10 years' experience in quality roles within biotechnology/pharmaceutical industry.
• Eligibility to act as a Qualified Person with demonstrable knowledge of biologics.
• Experience in GMP-regulated pharmaceutical environments.

Responsibilities

• Certifying and authorising batch releases in compliance with regulations.
• Overseeing Quality management systems and ensuring compliance.
• Participating in regulatory inspections and audits.

Skills

Knowledge of biologics and sterile manufacturing

Expertise in Pharmaceutical Quality Management Systems

Strong communication skills

Agile and innovative mindset

Education

Life Science degree

Postgraduate qualification

Tools

Quality Risk Management (QRM) tools

Job description

**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.**Here's What You’ll Do****Your key responsibilities will be:*** 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.**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.* 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.**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.** 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.**Here's What You'll Bring to the Table** To be successful in this role, you will have the following experience, qualifications and behaviours.* 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.**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 extrasThe 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