Senior Specialist, On-the-Floor, Quality Assurance
Moderna · Melbourne
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.
Here's What You'll Do:
Provide real-time, on-the-floor Quality Assurance support across Manufacturing and Quality Control operations through direct observation of manufacturing activities, laboratory execution, and operational practices against approved procedures, batch records, analytical methods, and product specifications.
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 data-driven quality decisions.
Support oversight of external and contract laboratories where applicable, including qualification activities, audits, quality agreements, and ongoing performance governance.
Support inspection readiness across laboratories, manufacturing suites, and the broader site by participating in walkthroughs, audit preparation activities, health authority inspection support, including TGA inspections, and inspection response activities.
Coach and mentor Manufacturing and QC personnel through real-time quality feedback, walkthrough observations, training support, and reinforcement of GMP, GDP, data integrity, and Quality System expectations.
Collaborate with QA On-the-Floor teams across the Moderna manufacturing network to align quality oversight practices, share operational learnings, and implement global best practices.
Apply operational and Quality Control knowledge to continuously improve quality, compliance, and operational efficiency across site activities.
Contribute to digital transformation initiatives by supporting responsible implementation of digital quality technologies, analytical tools, and AI-enabled opportunities that strengthen quality oversight and operational excellence.
Undertake additional responsibilities as assigned to support evolving business and operational needs.
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.
Supporting rapidly evolving manufacturing processes, analytical platforms, laboratory systems, digital technologies, and global quality expectations requires continuous learning. You'll embrace new regulatory developments, emerging quality practices, AI-enabled tools, and shared learnings across Moderna's global network to continuously strengthen quality oversight.
We behave like owners. The solutions we’re building go beyond any job description.
Success in this role requires ownership that extends beyond routine Quality Assurance oversight. You'll proactively identify risks, make pragmatic quality decisions, strengthen manufacturing and Quality Control operations, collaborate across multiple functions, and continuously improve systems that ultimately protect patients and support Moderna's mission
Here's What You'll Need (Basic Qualifications)
Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent combination of education and experience.
Minimum 5 years of pharmaceutical, biopharmaceutical, or related work experience with an emphasis on current Good Manufacturing Practices.
Working knowledge of Quality Systems and use of electronic systems such as SAP, LIMS, MODA, eLN, CDS, electronic batch records, or similar systems for batch release, deviations, lab data management, and manufacturing execution.
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.
Here's What You'll Bring to the Table (Preferred Qualifications)
Strong working knowledge of cGMP regulations, ISO standards, data integrity expectations, and relevant regulatory guidance.
Experience providing QA on-the-floor support in manufacturing operations, QC laboratories, or both.
Experience with regulatory inspections or audits as a Subject Matter Expert (SME), including direct interaction with health authorities or external auditors.
Experience with analytical or microbiological method validation, transfer, qualification, or lifecycle management.
Experience with OOS/OOT investigation management, deviations, CAPAs, risk assessments, and digital quality systems.
Understanding of QC microbiology, environmental monitoring, clean utilities, contamination control, and laboratory controls.
Demonstrated ability to make risk-based quality decisions and escalate issues appropriately.
Strong leadership, coaching, communication, project management, and organisational skills.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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.
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 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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