Manager, Quality Assurance for Quality Control, UK in Oxford

Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionising medicine through mRNA technology, with a diverse pipeline of development programmes across various diseases. As an employee, you will be part of a continually growing organisation, 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 are 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 Manager, Quality Assurance for Quality Control (QA for QC), you will provide comprehensive quality oversight for QC activities at our UK manufacturing sites—primarily the Harwell facility. You will serve as a critical member of the Quality Assurance function, ensuring that all QC operations align with cGMP, global regulations, and internal Moderna standards. This is an opportunity to help shape a strong quality culture, support complex lab operations, and contribute to Moderna’s mission by enabling a reliable and compliant analytical framework across our expanding global network. You will also play a central role in embedding inspection readiness into daily operations and have the chance to work with international sites, including Norwood, Madrid, and key external testing partners.

As part of Moderna’s cutting-edge work in mRNA manufacturing, this role also provides opportunities to engage with emerging technologies, including digital tools and platforms that accelerate compliance and decision-making.

Here’s What You’ll Do:

• 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 harmonisation 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.

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. This role requires you to take full ownership of QC oversight—supporting lab staff, influencing documentation practices, and escalating critical issues—all with a proactive and leadership-driven mindset. You will represent QA in cross-functional environments and be seen as a trusted authority.
• We digitise everywhere possible using the power of code to maximise our impact on patients. With Moderna's strong focus on innovation, this role offers opportunities to adopt digital quality systems and analytics platforms to enhance compliance and drive more agile decision-making in QC oversight.

Here’s What You’ll Need (Basic Qualifications):

• Education: Bachelor’s Degree in a scientific field.
• Experience: 8 – 10+ years of Biopharmaceutical / Pharmaceutical Industry within Quality.

As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre-employment check.

Here’s What You’ll Bring to the Table (Preferred Qualifications):

• 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, organisational, and communication skills.
• Experience interacting with regulatory authorities during regulatory inspections.
• Demonstrated ability making risk-based decisions.

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 programmes 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 extras.

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.