Quality Assurance for Quality Control – Australia

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.

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, 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.

Here’s What You’ll Do:

• 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.
• “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.

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, organizational, and communication skills.
• Experience interacting with regulatory authorities during regulatory inspections.
• Demonstrated ability making risk-based decisions.

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, 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.

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.