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. We behave like owners. The solutions we’re building go beyond any job description Here's What You'll Need (Basic Qualifications) 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, and validation lifecycle management in a GMP-regulated environment.

Experience

with deviations, investigations, CAPAs, change controls, and risk assessments.

Experience

supporting QC laboratory validations, investigations, and escalation in a GMP-regulated environment. Demonstrated risk-based decision making and strong technical writing for GMP and validation documentation. Strong cross-functional communication skills, with experience supporting audits and inspections. Here's What You'll Bring to the Table (Preferred Qualifications)

Experience

supporting sterile drug product manufacturing.

Experience

with process performance qualification, continued process verification, and drug product equipment qualification.

Experience

supporting QC laboratory equipment qualification and GMP laboratory quality systems.

Experience

applying formal quality risk management methodologies to process, equipment, system, or laboratory changes.

Experience

supporting technology transfer, startup, or commissioning in a highly regulated manufacturing environment. Pay &

Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive 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, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future Location-specific perks and extras The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic

Qualifications

for the role and you would be excited to contribute to our mission every day, please apply! Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home