Principal Specialist QA Tech Ops

BioSpace; City of Melbourne; On-site; AUD 150,000 - 210,000; Full time

Benefits offered by this job

Healthcare benefits

Flexible work options

Paid parental leave

Job summary

Moderna Australia in Melbourne seeks a QA professional to ensure quality, compliance, and technical excellence of mRNA manufacturing operations.

You will work across manufacturing, validation, technology transfer, and quality systems, delivering inspection-ready operations and data-driven decisions.

The role emphasizes collaboration with Operations, MS&T, Engineering, QC, and Supply Chain, while advancing a strong quality culture.

Qualifications

• Bachelor's degree in a science or engineering discipline, or equivalent.
• 5+ years of pharmaceutical quality, validation, or GMP experience.
• Experience with equipment qualification and process validation in a GMP-regulated environment.
• Experience with deviations, investigations, CAPAs, change controls, and risk assessments.
• Experience supporting QC laboratory validations, investigations, and escalation in a GMP-regulated environment.
• Demonstrated risk-based decision making and strong technical writing for GMP and validation documentation.

Responsibilities

• Provide quality oversight across manufacturing operations and QC laboratory validation activities.
• Lead or support validation lifecycle activities including PPQ and CPV.
• Review validation documentation and risk assessments.
• Act as QA escalation point for issues.
• Support regulatory audits and inspection readiness.
• Collaborate with cross-functional teams to manage validation risks.

Skills

Quality oversight

Validation

GMP experience

Cross-functional communication

Technical writing

Audits & inspections support

Education

Bachelor's degree in science or engineering

Job description

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.

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 growing Quality team in Melbourne and play a pivotal role in ensuring the quality, compliance, and technical excellence of Australia's large-scale mRNA manufacturing operations. Working across manufacturing, validation, technology transfer, and quality systems, you'll help build and sustain inspection-ready operations while partnering with cross-functional teams to deliver innovative medicines safely and efficiently. This role also offers opportunities to work alongside advanced digital technologies and emerging Generative AI-enabled tools that continue to enhance quality, operational excellence, and data-driven decision-making across the business.

Here’s What You’ll Do

• Provide quality oversight across manufacturing operations, technology transfer activities, GMP facility initiatives, and QC laboratory quality support, with primary responsibility for drug product validation, including equipment qualification, process validation, lifecycle validation management, analytical method validation, and associated laboratory validation activities.
• Provide quality oversight for commissioning, qualification, and validation of manufacturing equipment, systems, facilities, and critical utilities.
• Support the full process validation lifecycle, including validation strategy, process performance qualification (PPQ), continued process verification (CPV), and management of changes impacting validated state.
• Provide QA oversight for QC laboratory validation activities, including equipment qualification, laboratory system changes, and validation activities affecting product quality or validated state.
• Lead or support quality review of QC laboratory investigations, deviations, CAPAs, and change controls, ensuring timely, scientifically sound assessment and resolution.
• Act as the primary QA escalation point for technical, operational, validation, and QC laboratory issues, applying risk-based decision making to support effective resolutions.
• Review and approve validation documentation, including protocols, reports, discrepancy assessments, change controls, and risk assessments, ensuring alignment with site and global quality system requirements.
• Provide quality oversight for product technology transfers, process implementation activities, and technical changes impacting manufacturing processes, validated systems, and QC laboratory operations.
• Ensure manufacturing and supporting activities are executed in accordance with approved procedures, validated process parameters, equipment qualification requirements, and established control strategies.
• Lead or support quality review of deviations, investigations, CAPAs, and change controls relating to validation, manufacturing processes, technical operations, and QC laboratory activities.
• Partner closely with Operations, Manufacturing Sciences & Technology (MS&T), Engineering, Facilities, QC, Supply Chain, and Quality teams to proactively identify, assess, and manage validation, process, laboratory compliance, and operational risks.
• Apply Quality Risk Management principles to technical assessments, change evaluations, deviation investigations, escalation decisions, and activities affecting product quality or validated state.
• Review and approve GMP documentation, including SOPs, specifications, technical reports, validation protocols, validation summary reports, forms, and associated quality records.
• Support GMP material release activities and batch disposition, where applicable.
• Contribute to inspection and audit readiness through participation in internal audits, client audits, and regulatory inspections.
• Lead or support the preparation of inspection responses and implementation of remediation actions arising from audit or regulatory observations.
• Maintain a strong floor presence, providing visible QA oversight to ensure compliance with GMP requirements, validated operating practices, approved procedures, and documentation standards.
• Coach manufacturing and support teams on validation principles, documentation practices, investigation quality, and risk-based quality expectations to strengthen operational execution and quality culture.
• Drive continuous improvement of validation systems, technical quality processes, laboratory quality support, and operational readiness to enhance compliance, robustness, and efficiency.
• Support the development of QA team members and contribute to building technical capability across the Quality function.
• Provide strong technical judgement, collaborative leadership, and visible QA partnership to ensure the ongoing quality and compliance of Moderna's manufacturing operations in Australia.
• Bring significant experience providing pharmaceutical quality oversight within commercial GMP manufacturing environments.
• Demonstrate deep expertise in validation, technical quality, manufacturing operations, and pharmaceutical quality systems.
• Apply scientific thinking and Quality Risk Management principles to complex technical and compliance challenges.
• Build trusted partnerships across multidisciplinary teams to support compliant and efficient manufacturing operations.
• Thrive in a fast-paced environment, balancing strategic quality oversight with operational execution.
• Champion a proactive quality culture that supports innovation, continuous improvement, inspection readiness, and patient impact.

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.
• We behave like owners. The solutions we’re building go beyond any job description

Here’s What You'll Need (Basic Qualifications)

• Bachelor's degree in a science or engineering discipline, or equivalent combination of education and experience.
• 5+ years of pharmaceutical quality, validation, or related GMP experience.
• Experience with equipment qualification, process validation, and validation lifecycle management in a GMP-regulated environment.
• Experience with deviations, investigations, CAPAs, change controls, and risk assessments.
• Experience supporting QC laboratory validations, investigations, and escalation in a GMP-regulated environment.
• Demonstrated risk-based decision making and strong technical writing for GMP and validation documentation.
• Strong cross-functional communication skills, with experience supporting audits and inspections.

Here’s What You'll Bring To The Table (Preferred Qualifications)

• Experience supporting sterile drug product manufacturing.
• Experience with process performance qualification, continued process verification, and drug product equipment qualification.
• Experience supporting QC laboratory equipment qualification and GMP laboratory quality systems.
• Experience applying formal quality risk management methodologies to process, equipment, system, or laboratory changes.
• Experience supporting technology transfer, startup, or commissioning in a highly regulated manufacturing environment.

Pay & Benefits

• 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
• 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 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.

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.

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,

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 [e-mail].