Quality Assurance for Quality Control, Australia

The Role

This position offers the chance to join a pioneering mRNA-focused company that is reshaping how medicines are developed and delivered. You will be part of a fast-growing global organization working with highly skilled colleagues and partners across multiple regions, contributing to initiatives that support better health outcomes worldwide.

In Australia, the company is investing in a long-term biotech partnership aimed at strengthening pandemic readiness and building local capability. Its Melbourne-based large-scale mRNA vaccine manufacturing facility is expected to play an important role in future health response, while also creating jobs and developing local talent.

This is a high-impact individual contributor position responsible for providing Quality Assurance oversight to the Quality Control function at the Melbourne Resilience site in Clayton. The role is central to maintaining compliance with global cGMP requirements, pharmacopoeial standards, and internal quality systems.

You will support laboratory operations end to end, ensure alignment with QC practices across global sites such as Norwood, Madrid, and other Resilience locations, and help maintain continuous inspection readiness across the QC function. The position requires strong technical capability, coordination across sites, and a practical, risk-aware approach to improvement and compliance.

Key Responsibilities

• Provide QA oversight for QC systems, laboratory controls, documentation, data integrity, and computerized platforms such as LIMS, CDS, and eLN, with full ALCOA+ compliance.
• Support the lifecycle management of analytical methods, including qualification, validation, and transfer, in accordance with ICH Q2(R2), USP/Ph. Eur., FDA, TGA, and EMA expectations.
• Lead QA oversight of QC microbiology activities, including environmental monitoring, clean utilities, and contamination-control alignment with global strategy.
• Ensure GMP compliance across QC operations through review and approval of SOPs, APQRs, reports, and technical protocols.
• Apply risk-based decision-making using ICH Q9 principles to prioritize QA oversight and assessments.
• Prepare the laboratory for TGA and other global health authority inspections, including readiness planning, walkthroughs, and audit responses.
• Oversee OOS, OOT, and deviation investigations with focus on timely escalation, effective CAPA, and sound scientific rationale.
• Support qualification, auditing, and quality-agreement governance for external and contract laboratories around the world.
• Coach QC team members through QA walkthroughs, live data reviews, and training support.
• Maintain oversight of stability programs and the lifecycle of reference standards, critical reagents, and working materials.
• Ensure adherence to GDP, data integrity expectations, and training requirements, supported by thorough documentation practices.
• Review QC data trends to identify risks, improve processes, and support data-driven decisions.
• Align QC oversight practices with other manufacturing and testing sites to promote consistency and shared learning.
• Contribute to global analytical initiatives, including the use of generative AI tools to improve QC performance and digital transformation opportunities.
• Escalate compliance risks promptly to site and global Quality leadership.
• Provide occasional shift coverage or on-call support when needed.

Mindsets for Success

• Learn quickly and continuously, especially as laboratory platforms, systems, regulations, and digital tools evolve.
• Act with ownership by identifying risks early, suggesting improvements, and helping the wider QC network reach high standards of performance, integrity, and compliance.

Basic Qualifications

• Bachelor’s degree in a scientific discipline.
• 7 years of experience in the biopharmaceutical or pharmaceutical industry.
• This role may be subject to pre-employment and periodic medical assessments in line with applicable legal and operational requirements.

Preferred Qualifications

• Strong practical knowledge of cGMP rules, ISO standards, and related regulatory guidance.
• Prior experience serving as a subject matter expert during regulatory inspections, including direct engagement with global health authorities.
• Background in analytical or microbiological method validation.
• Experience managing OOS/OOT investigations, risk assessments, and digital quality systems.
• Proven leadership ability with experience developing, mentoring, and motivating diverse teams.
• Strong project management, organization, and communication skills.
• Experience working with regulatory authorities during inspections.
• Ability to make decisions based on risk assessment.

Benefits and Additional Information

The company provides a broad range of benefits designed to support well-being at work and beyond. These may vary depending on the nature of employment and the country of work.

• Comprehensive healthcare coverage, plus optional benefit programs.
• Access to fitness, mindfulness, and mental health resources.
• Family-building support, including fertility, adoption, and surrogacy benefits.
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment options for future planning.
• Location-specific perks and extras.

The company was founded in 2010 with the goal of building a leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. It values a culture where employees can help shape the future of medicine and make a meaningful impact.

An in-person work culture is considered important to success, supported by a 70/30 work model that keeps most work days onsite to encourage collaboration, innovation, and mentoring.

The workplace is smoke-free, alcohol-free, and drug-free.

The organization is an equal opportunity employer and does not discriminate on the basis of 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 family status, or any other legally protected characteristic. Qualified applicants are considered regardless of criminal history, where permitted by law.

Reasonable accommodations or adjustments are available for qualified applicants with disabilities for the hiring process and to perform essential job functions. Requests can be made through the accommodations and adjustments team.