Senior Specialist, On-the-Floor, Quality Assurance

About the role

Join Moderna's Quality organization as a Senior Specialist on the QA On-the-Floor team, providing real‑time quality assurance oversight for cGMP mRNA drug substance production. You will work at the point of execution, partnering with Manufacturing, QC, and cross‑functional teams to ensure compliant, efficient, and high‑quality operations.

Key responsibilities

• Provide on‑floor QA support through direct observation of manufacturing activities, laboratory execution, and operational practices.
• Perform routine walkthroughs of manufacturing suites and QC laboratories to verify facility conditions, aseptic behaviours, contamination control, and GMP compliance.
• Make timely, risk‑based quality decisions, escalating concerns to Site and Quality Leadership as needed.
• Oversee shift‑based manufacturing activities and support QC operations, including on‑call coverage.
• Partner with cross‑functional teams to manage deviations, CAPAs, change controls, and quality risk assessments.
• Review and approve quality documentation such as SOPs, protocols, batch records, and Annual Product Quality Review inputs.
• Conduct risk‑based assessments aligned with ICH Q9 principles and ensure data integrity per ALCOA+.
• Support method lifecycle activities, microbiology oversight, stability programmes, and external laboratory governance.
• Assist with inspection readiness, audit preparation, and health authority inspection support.
• Coach and mentor Manufacturing and QC personnel on GMP, GDP, and quality system expectations.

Required profile

• Bachelor's degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent experience.
• Minimum 5 years of pharmaceutical/biopharmaceutical experience with a strong focus on current Good Manufacturing Practices.
• Demonstrated ability to make independent technical judgments and provide real‑time quality guidance.

Required skills

• Working knowledge of cGMP and quality systems.
• Experience with electronic systems such as SAP, LIMS, MODA, eLN, and CDS.
• Understanding of ICH Q9 risk management and ALCOA+ data integrity principles.
• Proficiency in reviewing batch records, laboratory documentation, and GMP documentation.