Quality Assurance for Quality Control, Australia

The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, 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 is committed to enhancing Australia's biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility will be a cornerstone in Australia's ability to respond to future health threats efficiently. This collaboration not only brings cutting-edge medical technology to the forefront but also emphasizes job creation and local talent development. We're inviting visionary professionals to be part of this transformative journey, making a tangible impact on global health security. This is a high-impact individual contributor role providing Quality Assurance (QA) oversight to the Quality Control (QC) function at Moderna’s Melbourne-based Resilience site in Clayton. The position plays a pivotal role in ensuring QC operations comply with global cGMP regulations, pharmacopoeial standards, and internal quality policies. You’ll support end-to-end laboratory operations, align QC practices with global Moderna sites (including Norwood, Madrid, and other Resilience sites), and ensure 24/7 inspection readiness across the QC function. Your work will support Moderna’s rapidly advancing pipeline, requiring deep technical competence, cross-site coordination, and a proactive approach to risk management and continuous improvement. This is a globally integrated role, offering unique opportunities to collaborate with teams across Moderna’s global QC ecosystem while also contributing to key local operations at a state-of-the-art manufacturing facility in Australia. Here’s What You’ll Do: Your key responsibilities will be: Providing QA oversight of QC systems, laboratory controls, documentation, data integrity, and computerised systems (e.g., LIMS, CDS, eLN), ensuring full ALCOA+ compliance. Supporting analytical method lifecycle management including qualification, validation, and transfer in line with ICH Q2(R2), USP/Ph. Eur., FDA, TGA and EMA expectations. Leading QA oversight of QC microbiology operations including environmental monitoring, clean utilities, and contamination control alignment with global strategy. Ensuring GMP compliance in all QC activities, including review and approval of SOPs, APQRs, reports, and technical protocols. Conducting risk-based assessments under ICH Q9 for decision-making and prioritisation of QA oversight. Driving lab readiness for TGA and other global health authority inspections, leading preparations, walkthroughs, and audit response. Overseeing Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation investigations with an emphasis on timely escalation, CAPA effectiveness, and scientific justification. Supporting oversight of external/contract laboratories globally, including qualification, auditing, and quality agreement governance. Your responsibilities will also include: Coaching and guiding QC staff through QA lab walkthroughs, real-time data reviews, and training support. Maintaining robust oversight of stability programs and lifecycle management of reference standards, critical reagents, and working materials. Ensuring all personnel adhere to GDP, Data Integrity, and training requirements, with comprehensive documentation practices. Performing QC data trending and analysis to identify risks, drive process improvements, and ensure data-driven decision-making. Aligning QC oversight strategies ... (truncated, view full listing at source)