Moderna · 1 month ago
Manager, Quality Assurance for Quality Control, UK
Quality
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expModerna is a pioneering company in the field of mRNA technology, dedicated to revolutionizing medicine. The Manager, Quality Assurance for Quality Control (QA for QC) will oversee quality compliance for QC activities at the UK manufacturing sites, ensuring alignment with global regulations and internal standards while fostering a strong quality culture.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
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
Qualification
Required
Bachelor's Degree in a scientific field
8 – 10+ years of Biopharmaceutical / Pharmaceutical Industry within Quality
Strong working knowledge of cGMP regulations, ISO standards, and other relevant regulatory guidance document
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
Experience interacting with regulatory authorities during regulatory inspections
Demonstrated ability making risk-based decisions
Benefits
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments
Location-specific perks and extras!
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
H1B Sponsorship
Moderna has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (42)
2024 (49)
2023 (55)
2022 (23)
2021 (58)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
2026-01-22
Latest News From Euronews | Euronews RSS
2026-01-22
Company data provided by crunchbase