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Team Lead, Quality Control, Raw Materials & Environmental Monitoring

External
Moderna logoModerna · Melbourne, Australia
Full-timeRemote2w ago
ComplianceDocumentationLeadershipStakeholder Management
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About 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. Reporting to the Associate Director of Quality Control, you will lead critical QC operations overseeing raw materials, environmental monitoring, and critical utilities within a cGMP environment. You will operate at the intersection of quality, manufacturing, and innovation enabling compliance while enabling the speed and scale of mRNA production. This afternoon-shift leadership role offers the opportunity to drive operational excellence, mentor high-performing teams, and contribute to next-generation digital and AI-enabled quality systems. Here's What You'll Do: Lead, coach, and develop a team of QC analysts, fostering an inclusive, high-performance culture grounded in accountability and continuous learning. Oversee raw material and consumable sampling and testing activities, ensuring full compliance with cGMP and global regulatory requirements. Coordinate and optimize scheduling and prioritization of QC testing activities to meet dynamic production timelines. Manage Environmental Monitoring (EM) and Critical Utilities (CU) programs, including sampling, testing, data trending, and reporting. Ensure compliant and efficient shipment of samples to external laboratories, maintaining regulatory and quality standards. Review and approve analytical data within electronic laboratory systems, ensuring accuracy, completeness, and data integrity. Lead timely execution of investigations, deviations, CAPAs, and change controls, consistently meeting KPI expectations. Identify operational risks proactively and implement robust mitigation strategies to ensure uninterrupted quality operations. Collaborate cross-functionally with Manufacturing, Quality Assurance, MS&T, and external partners to ensure seamless operations. Author, review, and approve SOPs and work instructions, ensuring documentation remains current and compliant. Support regulatory inspections and audits, acting as a subject matter expert for raw materials, EM, and CU programs. Drive continuous improvement initiatives, leveraging digital tools and emerging technologies-including opportunities to integrate AI-driven insights-to enhance efficiency and compliance. Ensure strict adherence to safety, quality, and documentation standards across all QC activities. Support method transfers, validation, and qualification activities as required to enable process scalability and robustness. Provide flexible support across broader QC functions to meet evolving operational needs within Moderna's manufacturing environment. Operate effectively on an afternoon shift, ensuring extended coverage for manufacturing and QC activities. The key Moderna Mindsets you'll need to succeed in the role: "We act with urgency; Action today compounds the lives saved tomorrow." "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 degree in a relevant scientific discipline with 10+ years QC experience in a cGMP environment. Proven leadership experience with the ability to motivate, develop, and manage high-performing teams. Strong knowledge of environmental monitoring programs and raw material testing requirements. Demonstrated decision-making capability in a fast-paced, regulated environment. Proactive mindset with the ability to anticipate issues and drive solutions. Strong communication and stakeholder management skills. Passion for quality, continuous improvement, and operational excellence. Willingness to learn and adapt in a dynamic environment. Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment. Proven ability to conduct investigations. Experience with regulatory inspections and audit readiness. 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 health and safety, this role may be subject to pre-employment and periodic medical assessments, in line with relevant legal and operational requirements. Pay & Benefits 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, adoptio

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