Principal Specialist, Quality Assurance Compliance

The Role

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.​

The Principal Specialist – QA Compliance will play a crucial role in supporting the Quality Management System (QMS) processes and operations at Moderna’s Clayton (Melbourne), Australia site. This position ensures the highest level of compliance by overseeing the application of Moderna’s QMS in support of the internal manufacturing of commercially registered products.

You will be responsible for assessing and monitoring QMS health, driving continuous improvement, and fostering a cross-functional culture of quality across the site. Additionally, this role will support health authority inspections, internal audits, compliance reporting, records management, and training initiatives to maintain the site's inspection readiness.

Here’s What You’ll Do

Your key responsibilities will be:

• Maintain Moderna’s QMS, ensuring compliance with evolving regulatory requirements and industry best practices.

• Support deviation management, change control, gap analysis, risk assessments, and compliance reporting, ensuring proper documentation and timely resolution.

• Oversee records management, Annual Product Quality Reviews (APQRs), training documentation, and compliance tracking to sustain regulatory adherence across the site.

• Participate in internal audits and inspection readiness activities, contributing to preparation for regulatory inspections.

• Collaborate with quality, operations, and regulatory teams to ensure continued compliance with evolving industry standards.

Your responsibilities will also include:

• Identifying opportunities for process improvements and contributing to initiatives that enhance the efficiency and effectiveness of Moderna’s QMS.

• Acting as a key support resource for compliance-related activities, providing documentation, reports, and guidance as needed.

• Supporting a culture of quality across the site by fostering collaboration and ensuring best practices in QMS application.

The key Moderna Mindsets you’ll need to succeed in the role:

• We obsess over learning – This role requires continuous improvement and proactive identification of gaps in compliance, meaning you will need to stay ahead of regulatory trends, audit best practices, and QMS innovations.

• We behave like owners – In a compliance-driven environment, taking ownership of the QMS processes and ensuring seamless execution is key to maintaining Moderna’s high standards of operational excellence.

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

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Quality, Regulatory Compliance) or equivalent experience.

• > 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Experience in QMR, Quality Management Systems (QMS), Change control, Deviations management, GXP compliance, or pharmaceutical/biotech regulations is desirable.

• Experience in a Quality or Compliance role in the pharmaceutical industry preferred

• Strong attention to detail, organizational skills, and ability to manage multiple priorities.

• Excellent communication and problem-solving skills.

• Ability to collaborate across teams and contribute to a culture of continuous improvement.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

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.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments
• 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, 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.  

By living our mission, values, and mindsets every day, our people are 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. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers 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 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 [email protected]. 

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