Principal Specialist Quality Assurance Compliance

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 longterm partnership that focuses on strengthening pandemic resilience.

Our Melbournebased largescale mRNA vaccine manufacturing facility will be a cornerstone in Australias ability to respond to future health threats efficiently.

This collaboration not only brings cuttingedge 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.

The Principal Specialist QA Compliance will play a crucial role in supporting the Quality Management System (QMS) processes and operations at Modernas Clayton (Melbourne) Australia site. This position ensures the highest level of compliance by overseeing the application of Modernas 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 crossfunctional 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 sites inspection readiness.

Heres What Youll Do

Your key responsibilities will be:

• Maintain Modernas 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 Modernas QMS.

• Acting as a key support resource for compliancerelated 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 youll 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 compliancedriven environment taking ownership of the QMS processes and ensuring seamless is key to maintaining Modernas high standards of operational excellence.

Heres What Youll Need (Basic Qualifications)

• Bachelors 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 sitebased requiring you to be at Modernas site fulltime. This position is not eligible for remote work.

Heres What Youll 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 problemsolving skills.

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

• A desire to make an impact as part of a highgrowth 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. Thats why our global benefits and wellbeing resources are designed to support youat work at home and everywhere in between.

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to wellbeing
• 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 yearend shutdown
• Savingsandinvestments
• Locationspecific 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 worldclass 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 inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice 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/careers to learn more about our current opportunities.

Moderna is a smokefree alcoholfree and drugfree 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 nondiscrimination 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 .