Quality Assurance for Quality Control, Australia

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas 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 Australias 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 Australias 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. Were 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 Modernas 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.

Youll 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 Modernas 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 Modernas global QC ecosystem while also contributing to key local operations at a state-of-the-art manufacturing facility in Australia.

Heres What Youll 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 youll need to succeed in the role:

• We obsess over learning. We dont have to be the smartest we have to learn the fastest.
  This mindset is essential as youll 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 were 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 Modernas global QC network operates at best-in-class levels of performance integrity and compliance.

Heres What Youll Need (Basic Qualifications)

• Education: Bachelors Degree in a scientific field.

• Experience: 7 years of Biopharmaceutical / Pharmaceutical Industry.

• As part of Modernas 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.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Strong working knowledge of cGMP regulations ISO standards and other relevant regulatory guidance document.

• 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.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our global benefits and well-being resources are designed to support youat 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

• Savingsandinvestments 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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 persons 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.

Were 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 .

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