Qualified Person, UK

Act as the named Qualified Person (QP) on Moderna's site license(s).,Certify and authorize 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.,Participate as a member of the site and country Quality teams, promoting strong quality culture and QRM principles.,Attend and report at the Quality Management Review Forum.,Oversee delegated activities and ensuring 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 ensuring 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.

A Life Science degree and/or relevant postgraduate qualification.,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).

Bachelor's Degree

Must be willing to maintain QP status through ongoing Continuing Professional Development.