Principal Specialist, QA Technical Operations

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.​

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 real-time quality oversight of manufacturing operations and be a key leader in ensuring the compliance, efficiency, and optimization of materials management within a GMP-regulated 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.

Here’s What You’ll Do

Your key responsibilities will be:

• Overseeing end-to-end 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 intra-company 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 execution 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 cross-functional projects to enhance operational efficiency, quality compliance, and risk-based decision-making.

The key Moderna Mindsets you’ll 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 high-quality 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 data-driven decisions that improve operational performance.

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

• Bachelor’s 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 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)

• Sterile drug product manufacturing experience preferred

• 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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