Principal Specialist QA Tech Ops

About the Role Moderna is seeking a Principal Specialist QA Tech Ops to provide quality oversight across manufacturing operations, technology transfer activities, GMP facility initiatives, and QC laboratory-related quality support, with primary focus on drug product validation, including equipment qualification, process validation, lifecycle validation management, analytical method validation and associated laboratory validation support. This role reports to the Site Quality Head and aims to ensure that validation and manufacturing activities are scientifically sound, inspection-ready, and aligned with site and global quality system requirements. The successful candidate will partner with Operations, MS&T, Engineering, Facilities, QC, Supply Chain, and other Quality functions to strengthen compliance and operational readiness in Australia. What You'll Do

• Provide quality oversight for commissioning, qualification, and validation activities associated with drug product manufacturing equipment, systems, facilities, and critical utilities.
• Support and provide QA oversight for the process validation lifecycle, including validation strategy, process performance qualification, continued process verification, and changes impacting validated state.
• Provide quality oversight for QC laboratory-associated validation activities, including equipment qualification, laboratory systems changes, and other validation-related activities that may impact product quality or validated state.
• Support and/or lead quality review of QC laboratory investigations, deviations, CAPAs, and change controls, ensuring issues are appropriately assessed, escalated, and resolved in a timely and scientifically sound manner.
• Act as a key QA escalation point for technical, operational, and QC laboratory validation or investigation issues, supporting timely issue resolution and sound, risk-based decision making.
• Review and approve validation documentation, including protocols, reports, discrepancy assessments, change controls, and risk assessments, ensuring records are scientifically sound, timely, and aligned with site and global quality system requirements.
• Provide quality oversight for product technology transfers, process implementation activities, and technical changes impacting drug product manufacturing processes, validated systems, or associated QC laboratory activities.
• Ensure manufacturing and associated support 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 related to validation, technical operations, manufacturing processes, and QC laboratory support activities.
• Partner closely with Operations, Facilities, MS&T, QC, Engineering, Supply Chain, and Quality to proactively identify, assess, and manage validation, process, laboratory, and compliance risks across site activities.
• Apply quality risk management tools and principles to support technical assessments, change evaluations, deviation investigations, escalation decisions, and actions affecting product quality or validated state.
• Review and approve GMP documentation such as SOPs, forms, technical reports, specifications, validation protocols, validation summary reports, and associated records.
• Support and undertake quality review activities associated with GMP release of materials and/or batch disposition, as applicable.
• Serve as a key contributor to inspection and audit readiness, including internal audits, client audits, and regulatory inspections.
• Lead or support drafting of inspection and audit responses, and the development and implementation of remediation actions arising from observations related to technical operations, validation, QC laboratory support, and manufacturing controls.
• Conduct routine floor presence and quality oversight to confirm adherence to approved procedures, GMP requirements, validated operating practices, and documentation expectations.
• Coach operations and support personnel on validation principles, documentation practices, investigation quality, and risk-based quality expectations to strengthen operational execution and quality culture.
• Support the ongoing improvement of validation systems, technical quality processes, laboratory quality support, and operational readiness programs to enhance compliance, robustness, and efficiency.
• Support the training and development of QA team members and contribute to building technical capability across the function.
• Play a critical role in ensuring the overall quality and compliance of Moderna's manufacturing operations in Australia through strong technical judgment, collaboration, and visible QA leadership. What We're Looking For
• Bachelor's degree in a science or engineering discipline, or equivalent combination of education and experience.
• 5+ years of pharmaceutical quality, validation, or related GMP experience.
• Experience with equipment qualification, process validation, lifecycle validation management, analytical method validation and associated laboratory validation support.
• Strong experience in pharmaceutical quality oversight within commercial manufacturing environments.
• Ability to apply quality risk management principles to support compliant and efficient operations.
• Demonstrated ability to partner with Operations, MS&T, Engineering, Facilities, QC, Supply Chain, and Quality to manage validation, process, and compliance risks.
• Experience contributing to inspection readiness and regulatory audits.
• Sound scientific judgment and leadership in QA decision-making. Nice to Have
• Experience in drug product manufacturing at scale and across multiple sites.
• Prior exposure to Australian regulatory expectations and audits. Compensation & Benefits
• Not disclosed