Principal Specialist QA Tech Ops

The Role 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 strengthening its presence in Melbourne, a leading biotech hub in Australia. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global professionals committed to making a meaningful impact. Join Moderna's growing Quality team in Melbourne and play a pivotal role in ensuring the quality, compliance, and technical excellence of Australia's large-scale mRNA manufacturing operations. Working across manufacturing, validation, technology transfer, and quality systems, you'll help build and sustain inspection-ready operations while partnering with cross-functional teams to deliver innovative medicines safely and efficiently. This role also offers opportunities to work alongside advanced digital technologies and emerging Generative AI-enabled tools that continue to enhance quality, operational excellence, and data-driven decision-making across the business. Here’s What You’ll Do Provide quality oversight across manufacturing operations, technology transfer activities, GMP facility initiatives, and QC laboratory quality support, with primary responsibility for drug product validation, including equipment qualification, process validation, lifecycle validation management, analytical method validation, and associated laboratory validation activities. Provide quality oversight for commissioning, qualification, and validation of manufacturing equipment, systems, facilities, and critical utilities. Support the full process validation lifecycle, including validation strategy, process performance qualification (PPQ), continued process verification (CPV), and management of changes impacting validated state. Provide QA oversight for QC laboratory validation activities, including equipment qualification, laboratory system changes, and validation activities affecting product quality or validated state. Lead or support quality review of QC laboratory investigations, deviations, CAPAs, and change controls, ensuring timely, scientifically sound assessment and resolution. Act as the primary QA escalation point for technical, operational, validation, and QC laboratory issues, applying risk-based decision making to support effective resolutions. Review and approve validation documentation, including protocols, reports, discrepancy assessments, change controls, and risk assessments, ensuring alignment with site and global quality system requirements. Provide quality oversight for product technology transfers, process implementation activities, and technical changes impacting manufacturing processes, validated systems, and QC laboratory operations. Ensure manufacturing and supporting activities are executed in accordance with approved procedures, validated process parameters, equipment qualification requirements, and established control strategies. Lead or support quality review of deviations, investigations, CAPAs, and change controls relating to validation, manufacturing processes, technical operations, and QC laboratory activities. Partner closely with Operations, Manufacturing Sciences & Technology (MS&T), Engineering, Facilities, QC, Supply Chain, and Quality teams to proactively identify, assess, and manage validation, process, laboratory, compliance, and operational risks. Apply Quality Risk Management principles to technical assessments, change evaluations, deviation investigations, escalation decisions, and activities affecting product quality or validated state. Review and approve GMP documentation, including SOPs, specifications, technical reports, validation protocols, validation summary reports, forms, and associated quality records. Support GMP material release activities and batch disposition, where applicable. Contribute to inspection and audit readiness through participation in internal audits, client audits, and regulatory inspections. Lead or support the preparation of inspection responses and implementation of remediation actions arising from audit or regulatory observations. Maintain a strong floor presence, providing visible QA oversight to ensure compliance with GMP requirements, validated operating practices, approved procedures, and documentation standards. Coach manufacturing and support teams on validation principles, documentation practices, investigation quality, and risk-based quality expectations to strengthen operational execution and quality culture. Drive continuous improvement of validation systems, technical quality processes, laboratory quality support, and operational readiness to enhance compliance, robustness, and efficiency. Support the development of QA team members and contribute to building technical capability across the Quality function. Provide strong technical judgement, collaborative leadership, and visible QA partnership to ensure the ongoing quality and compliance of Moderna's manufacturing operations in Australia. Bring significant experience providing pharmaceutical quality oversight within commercial GMP manufacturing environments. Demonstrate deep expertise in validation, technical quality, manufacturing operations, and pharmaceutical quality systems. Apply scientific thinking and Quality Risk Management principles to complex technical and compliance challenges. Build trusted partnerships across multidisciplinary teams to support compliant and efficient manufacturing operations. Thrive in a fast-paced environment, balancing strategic quality oversight with operational execution. Champion a proactive quality culture that supports innovation, continuous improvement, inspection readiness, and patient impact. 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