Quality Assurance for Quality Control, Australia (Melbourne)

Joining Moderna offers the unique opportunity to be part of a pioneering team that’s revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you’ll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna’s commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience, with the potential to make a significant impact on patients’ lives worldwide. Moderna is committed to enhancing Australia’s biotech landscape through a long-term partnership that focuses on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility will be a cornerstone in Australia’s ability to respond to future health threats efficiently. This collaboration not only brings cutting-edge medical technology to the forefront but also emphasizes job creation and local talent development. We’re inviting visionary professionals to be part of this transformative journey, making a tangible impact on global health security. This is a high-impact individual contributor role providing Quality Assurance (QA) oversight to the Quality Control (QC) function at Moderna’s Melbourne-based Resilience site in Clayton. The position plays a pivotal role in ensuring QC operations comply with global cGMP regulations, pharmacopoeial standards, and internal quality policies. You’ll support end-to-end laboratory operations, align QC practices with global Moderna sites (including Norwood, Madrid, and other Resilience sites), and ensure 24/7 inspection readiness across the QC function. Your work will support Moderna’s rapidly advancing pipeline, requiring deep technical competence, cross-site coordination, and a proactive approach to risk management and continuous improvement. This is a globally integrated role, offering unique opportunities to collaborate with teams across Moderna’s global QC ecosystem while also contributing to key local operations at a state-of-the-art manufacturing facility in Australia. Here’s What You’ll Do Your key responsibilities will be
- Providing QA oversight of QC systems, laboratory controls, documentation, data integrity, and computerised systems (e.g., LIMS, CDS, eLN), ensuring full ALCOA+ compliance.
- Supporting analytical method lifecycle management including qualification, validation, and transfer in line with ICH Q2(R2), USP/Ph. Eur., FDA, TGA and EMA expectations.
- Leading QA oversight of QC microbiology operations including environmental monitoring, clean utilities, and contamination control alignment with global strategy.
- Ensuring GMP compliance in all QC activities, including review and approval of SOPs, APQRs, reports, and technical protocols.
- Conducting risk-based assessments under ICH Q9 for decision-making and prioritisation of QA oversight.
- Driving lab readiness for TGA and other global health authority inspections, leading preparations, walkthroughs, and audit response.
- Overseeing Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation investigations with an emphasis on timely escalation, CAPA effectiveness, and scientific justification.
- Supporting oversight of external/contract laboratories globally, including qualification, auditing, and quality agreement governance. Your responsibilities will also include
- Coaching and guiding QC staff through QA lab walkthroughs, real-time data reviews, and training support.
- Maintaining robust oversight of stability programs and lifecycle management of reference standards, critical reagents, and working materials.
- Ensuring all personnel adhere to GDP, Data Integrity, and training requirements, with comprehensive documentation practices.
- Performing QC data trending and analysis to identify risks, drive process improvements, and ensure data-driven decision-making.
- Aligning QC oversight strategies with other Moderna manufacturing and testing sites to ensure consistency and shared learning.
- Participating in or supporting global analytical initiatives involving generative AI tools to enhance QC performance and digitalisation opportunities.
- Managing timely escalation of compliance risks to site and global Quality leadership.
- Occasionally participating in shift coverage or on-call rotations where required. 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.” This mindset is essential as you’ll be supporting evolving analytical platforms, new laboratory systems, and global QC harmonization efforts. Staying at the forefront of regulatory trends, digital tools, and emerging biotech innovations – including GenAI applications – is critical to thrive in this role.
- “We behave like owners. The solutions we’re building go beyond any job description.” As a QA lead for QC oversight, you will be expected to take initiative beyond routine review – proactively identifying risks, proposing strategic improvements, and ensuring Moderna’s global QC network operates at best-in-class levels of performance, integrity, and compliance. Here’s What You’ll Need (Basic Qualifications)
- Education: Bachelor’s Degree in a scientific field.
- Experience: 7 years of Biopharmaceutical / Pharmaceutical Industry.
- 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, and other relevant regulatory guidance documents.
- Experience with regulatory inspections as a Subject Matter Expert (SME), including direct interactions with worldwide health authorities.
- Demonstrated experience in analytical or microbiological method validation.
- Experience with OOS/OOT investigation management, risk management, and digital quality systems.
- Strong leadership skills with ability to develop, mentor, and motivate diverse teams.
- Excellent project management, organisational, and communication skills.
- Experience interacting with regulatory authorities during regulatory inspections.
- Demonstrated ability making risk-based decisions. Pay & Benefits
- 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, 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. Moderna is committed to equal chance 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. 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 . #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rszfl