Qualified Person

** 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 (e ) 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…