Principal Specialist QA Technical Operations

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.

In this role you will be an integral part of a cohesive team responsible for supporting cGMP mRNA drug substances and drug products produced internally at Moderna. You will provide realtime quality oversight of manufacturing operations and be a key leader in ensuring the compliance efficiency and optimization of materials management within a GMPregulated environment. The ideal candidate will have experience in quality oversight or manufacturing of commercial products and will leverage their expertise to drive operational excellence and compliance within warehouse and materials management operations.

Heres What Youll Do

Your key responsibilities will be:

• Overseeing endtoend materials management ensuring compliance with GMP requirements for raw materials components and finished goods.

• Ensuring warehouse operations follow quality and safety standards including material segregation environmental monitoring and storage conditions.

• Providing quality oversight for material transfers including intracompany movements supplier quality assessments and disposition processes.

• Collaborating with Supply Chain Quality and Manufacturing teams to enhance material flow traceability and inventory accuracy.

• Taking ownership of the site Deviation program and metrics including facilitation of the Material Review Board.

Your responsibilities will also include:

• Driving troubleshooting and system optimization initiatives to enhance SAP functionality for warehouse and batch record management.

• Performing batch record reviews to ensure compliance with GMP requirements accuracy in documentation and proper of manufacturing and warehouse operations.

• Supporting the batch disposition process working closely with Quality Assurance and Manufacturing teams to facilitate timely release of materials and final product.

• Managing and supporting deviations CAPAs and change controls ensuring timely investigation closure and corrective actions.

• Supporting internal and external audits including regulatory inspections with a focus on operational quality materials management warehouse operations SAP compliance and batch record review.

• Developing and delivering training initiatives on SAP governance warehouse quality and batch record documentation best practices.

• Acting as a key stakeholder in crossfunctional projects to enhance operational efficiency quality compliance and riskbased decisionmaking.

The key Moderna Mindsets youll need to succeed in the role:

• We behave like owners You will take full accountability for warehouse quality operations and materials management ensuring compliance efficiency and continuous improvement. You will be responsible for driving highquality outcomes and strategic decisions that impact manufacturing and supply chain success.

• We digitize everywhere possible You will leverage SAP and other digital systems to optimize warehouse management enhance traceability and drive efficiency in batch record documentation making datadriven decisions that improve operational performance.

Heres What Youll Need Basic Qualifications)

• Bachelors Degree in a science field (e.g. Biology Microbiology Chemistry Pharmacy Engineering) or equivalent combination of education and 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)

• Sterile drug product manufacturing experience preferred

• 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 .