Manager, Quality Assurance for Quality Control, UK

Provide strategic and operational quality oversight to QC laboratories at Harwell, aligned with Moderna's global quality framework.,Ensure QC methods, processes, and SOPs are scientifically robust, validated, and aligned with regulatory expectations (e.g., ICH Q2 (R2), USP/Ph. Eur.).,Lead the QA review and approval of laboratory-related documentation, such as SOPs, analytical reports, Annual Product Quality Reviews, and trend analyses.,Oversee qualification, validation, and transfer of analytical methods to internal and external labs, ensuring lifecycle management and scientific integrity.,Support continuous GMP compliance by ensuring adherence to Good Documentation Practices and Data Integrity standards.,Oversee and support OOS/OOT investigations to ensure they are prompt, unbiased, scientifically justified, and concluded with effective CAPAs.,Conduct on-the-floor QA oversight via lab walkthroughs, data reviews, and staff coaching.,Lead inspection readiness efforts and actively participate in hosting MHRA, FDA, and other regulatory inspections.,Monitor training, qualification, and competency records for QC personnel to ensure compliance.,Perform risk-based QA decision-making using ICH Q9 principles.,Oversee quality aspects of external/contract laboratories, including qualification and performance monitoring.,Execute trend analysis of QC data and verify CAPA effectiveness.,Maintain alignment with other Moderna labs (Norwood, Madrid, Resilience sites) and ensure harmonization where possible.,Foster an inclusive and quality-focused team culture that values collaboration and continuous improvement.,Ensure task execution follows internal SOPs and global policies precisely and compliantly.,Participate in on-call rotations or shift coverage when required to support 24/7 manufacturing operations.,Additional duties as assigned in alignment with evolving site priorities.

Bachelor's Degree in a scientific field or equivalent experience.,8 – 10+ years of Biopharmaceutical / Pharmaceutical Industry within Quality.,Strong working knowledge of cGMP regulations, ISO standards, and other relevant regulatory guidance documents.,Experience with regulatory inspections as a Subject Matter Expert (SME), including direct interactions with worldwide health authorities.,Demonstrated experience in analytical or microbiological method validation.,Experience with OOS/OOT investigation management, risk management, and digital quality systems.,Strong leadership skills with ability to develop, mentor, and motivate diverse teams.,Excellent project management, organizational, and communication skills.,Demonstrated ability making risk-based decisions.

Bachelor's Degree

May require an enhanced pre-employment check.,Participate in on-call rotations or shift coverage when required to support 24/7 manufacturing operations.