Senior Specialist, On-the-Floor, Quality Assurance
Moderna
Melbourne, Victoria, Australia
Full-Time
Competitive
RemoteSenior
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 Quality organization as part of our QA On-the-Floor team, where you'll provide real-time Quality Assurance oversight across internal manufacturing and Quality Control operations supporting cGMP mRNA drug substance production. Working at the point of execution, you'll partner across Manufacturing, QC, Manufacturing Science and Technology, Operations, Engineering, Facilities, and other technical teams to ensure compliant, efficient, and high-quality operations that ultimately impact patients worldwide.
This is a broad QA On-the-Floor role with a dedicated Quality Control focus, requiring strong technical judgment, independent decision-making, and the confidence to provide real-time quality guidance while escalating risks that could impact product quality, patient safety, compliance, or operational continuity. You'll play a critical role in strengthening Moderna's quality culture while contributing to continuous improvement, digital innovation, and responsible adoption of AI-enabled quality solutions.
Perform routine walkthroughs of manufacturing suites and QC laboratories to verify appropriate facility conditions, aseptic behaviours, contamination control practices, GMP compliance, documentation practices, and implementation of site quality standards.
Ensure adherence to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), work instructions, batch records, laboratory documentation requirements, and established quality expectations.
Make timely, risk-based quality decisions that support compliant operations while appropriately communicating and escalating quality concerns, operational gaps, and compliance risks to Site and Quality Leadership.
Provide shift-based QA oversight of manufacturing activities and support Quality Control operations, including occasional QC support and on-call coverage as required.
Promote a strong safety culture by consistently practicing safe work behaviours and adhering to Moderna safety procedures and guidelines.
Serve as a subject matter expert within Quality Systems, applying expertise across deviations, CAPAs, change controls, and quality risk management activities.
Partner with Manufacturing, QC, and cross-functional support teams to initiate, triage, assess, and manage deviation events, including manufacturing deviations, QC deviations, Out of Specification (OOS), Out of Trend (OOT) investigations, and laboratory non-conformances.
Provide quality oversight of investigations, ensuring timely escalation, scientifically sound justifications, robust root cause analysis, effective corrective and preventive actions, and sustainable CAPA implementation.
Author, review, and approve quality documentation including SOPs, work instructions, protocols, reports, Annual Product Quality Review (APQR) inputs, technical assessments, and other GMP documentation supporting compliant operations.
Review executed electronic and paper batch records, laboratory documentation, and supporting GMP records with a strong focus on Good Documentation Practices (GDP) and data integrity expectations.
Conduct risk-based assessments aligned with ICH Q9 principles to support prioritisation of QA activities, informed decision-making, and proactive compliance management.
Provide targeted Quality Assurance oversight of Quality Control systems, laboratory controls, documentation practices, data integrity, and computerized systems including LIMS, CDS, eLN, SAP, and MODA, ensuring alignment with ALCOA+ data integrity principles.
Support analytical and microbiological method lifecycle activities including method qualification, validation, transfer, change control, and ongoing performance monitoring in accordance with regulatory expectations.
Provide oversight of QC microbiology activities, including environmental monitoring programmes, clean utilities, contamination control strategies, and alignment with site and global contamination control expectations.
Maintain oversight of stability programmes together with lifecycle management of reference standards, critical reagents, and working materials.
Perform and support QC data trending and analysis to identify emerging quality risks, enable continuous improvement opportunities, and support >That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
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.
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