(Fixed Term) Data Quality Control Specialist. Clinical Biomarker Laboratory

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is establishing a leading research, development, and manufacturing facility at Harwell to support onshore mRNA vaccine production for respiratory diseases in the UK. This long‑term investment will create skilled jobs and strengthen collaboration with academic, NHS, and government partners. We welcome experts ready to help expand access to life‑saving vaccines.

Within the Clinical Biomarker Laboratory, this role sits at the critical intersection of data integrity, regulatory compliance, and clinical development execution. You will act as a key quality control partner, ensuring laboratory data generated in GCP‑regulated environments are inspection‑ready, fully traceable, and aligned to regulatory expectations. Operating as an individual contributor, you will work hands‑on with complex datasets, laboratory systems, and cross‑functional stakeholders to uphold the highest standards of clinical data quality while supporting evolving digital and data‑driven capabilities, including exposure to advanced data tooling and automation.

Here’s What You’ll Do:

• Adhere to analytical data quality and integrity standards in accordance with MHRA, ICH, GCP requirements, applicable regulations, and established SOPs across clinical studies.
• Perform comprehensive QC review of raw laboratory data (paper records, ELNs, instrument outputs, and electronic files), ensuring completeness, accuracy, and traceability to source data.
• Review calculations and data processing steps, confirming mathematical accuracy, correct formula application, dilution factors, acceptance criteria, and statistical methods.
• Ensure all calculations are reproducible from raw data and fully documented, including manual and system‑generated outputs.
• Review laboratory documentation (worksheets, methods, SOPs, study plans, protocols, amendments, and source documents) for completeness, consistency, and compliance.
• Conduct QC review of LIMS (LabVantage) entries, including sample metadata, test assignments, results, status changes, and approvals.
• Verify accuracy of data transcription into LIMS and ensure consistency between LIMS, raw data, and source documentation.
• Compare laboratory outputs against Data Transfer Specifications (DTS), ensuring correct structure, formatting, units, terminology, and completeness.
• Verify transferred data accurately reflect approved results and meet study‑specific and sponsor‑defined requirements.
• Review study plans, protocols, and reports to ensure alignment between planned work, executed laboratory activities, and reported outputs.
• Identify discrepancies, missing data, or inconsistencies; document findings and issue QC observations in line with procedures.
• Communicate data quality issues to scientific staff and study teams; support resolution through corrections, deviations, and CAPAs.
• Ensure ALCOA+ data integrity principles are applied across the full data lifecycle (generation through archival).
• Verify compliance of electronic records and signatures with 21 CFR Part 11, EU Annex 11, and internal governance standards.
• Contribute to deviation investigations, root cause analyses, and CAPA development related to data and documentation issues.
• Support Excel workbook validation, including formula review, data integrity controls, versioning, and documentation practices.
• Participate in review of protocols, analytical methods, reports, batch records, and GCP source documentation using systems such as Excel, LabVantage LIMS, and Veeva.
• Support internal and external audits by providing data traceability evidence and responding to data‑related inquiries.
• Collaborate with QA and cross‑functional teams to evolve the Quality Management System (QMS) and implement risk‑based quality approaches.
• Coordinate with internal and external stakeholders to improve laboratory data quality, processes, and analytical workflows.
• Deliver high‑quality, detail‑oriented work with efficiency in a fast‑paced, highly regulated laboratory environment.

The key Moderna Mindsets you’ll need to succeed in the role:

• We obsess over learning. We don’t have to be the smartest we have to learn the fastest.
• We digitize everywhere possible using the power of code to maximize our impact on patients.

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

• Bachelor's / Master’s / PhD degree in Biological Sciences or related scientific discipline, with strong background in quality data analytics.
• 3+ years of relevant clinical laboratory experience in the pharmaceutical industry or CROs including data analysis and QC review of data.
• Demonstrated experience performing independent QC review of complex analytical datasets, including reconciliation between raw data, processed results, and reported outputs.
• Knowledge in various lab‑based techniques such as LC/MS, immunoassays, cell‑based assays, cytometry, and other platforms for the investigation of biomarkers in clinical phase studies.
• Knowledge of Bioanalytical Method Validation for Industry is preferred.
• Knowledge of data management tools, electronic systems, and data integrity requirements.
• Previous experience working in GxP regulated laboratory is highly preferred.
• Hands‑on experience and knowledge of quality systems and regulatory requirements.
• Proficiency with Microsoft Office Suite (Outlook, Excel, Word, etc.).
• Proficiency with statistical analysis methodologies is a plus.
• Strong attention to detail, sound judgment, organizational ability, a team‑player attitude, and effective written and verbal communication skills.
• Ability to work effectively in a team environment while managing multiple concurrent projects and priorities.
• Ability to work independently while taking direction and adapting to changing study and business needs.

This position is site‑based, requiring you to be at Moderna’s site full‑time. This position is not eligible for remote work. As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre‑employment check.

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 programs 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.

Since our founding in 2010, we have aspired to build the leading mRNA technology platform to reimagine how medicines are created and delivered, and to develop a world‑class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.

Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!