Associate Director, Country Quality and Authorized Person, Australia

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 solidifying its presence in Melbourne, a city at the forefront of Australia’s biotech industry. Our Melbourne office focuses on commercial operations ensuring the delivery of our innovative products to the Australian market. We’re inviting international professionals to join us in our mission of delivering the greatest possible impact to people through mRNA medicines. This is a pivotal individual contributor position responsible for leading country‑level quality activities in Australia while serving as the designated Authorized / Responsible Person (AP / RP) under the Therapeutic Goods Administration (TGA) requirements. The Associate Director ensures Moderna’s mRNA products distributed in the Australian market fully comply with cGMP, GDP and local regulatory obligations. This role will build and continuously enhance Moderna’s local Quality Management System (QMS), act as the primary liaison with local and global regulatory stakeholders and play a key role in inspection readiness. It offers a unique opportunity to integrate digital innovation including Generative AI tools to further elevate quality processes and documentation standards. The individual will operate cross‑functionally with global quality functions, external partners and Australian authorities shaping the local quality framework to support Moderna’s expanding footprint. What You’ll Do Key Responsibilities Serve as the designated AP / RP under TGA accountable for GMP and GDP compliance in Australia. Review and approve batch manufacturing testing and release documentation to ensure alignment with internal standards and local regulations before final disposition. Maintain oversight of deviations, non‑conformances, change controls and ensure timely documentation and resolution. Drive implementation and continuous improvement of the local Quality Management System (QMS). Act as the local Quality liaison for all GxP compliance activities at the Clayton site. Prepare and lead Quality Management Reviews and monitor Quality KPIs. Coordinate audit readiness efforts and support external and internal inspections. Oversee interactions with third‑party logistics providers for GDP‑compliant product handling, storage and distribution. Support budget management and vendor scheduling for quality‑related functions. Lead documentation processes in strict adherence with Good Documentation Practices and data integrity requirements. Additional Responsibilities Create, revise and implement SOPs and work instructions supporting the QMS. Manage local execution of distribution procedures in compliance with GDP. Monitor pharmaceutical product stock levels including oversight of returns, batch recalls, shortage declarations and distribution authorisations. Support lifecycle oversight by contributing to relevant R&D study programmes. Manage complaint handling, recalls, risk assessments and medical queries in compliance with applicable frameworks. Ensure continuous training, personal development and adherence to required learning plans. Identify and assign qualified deputies to ensure continuity during absences. Foster a positive and inclusive work culture that embraces collaboration, innovation and continuous improvement. Rigorously apply all internal quality procedures and regulatory standards in daily operations. Ensure documentation is audit‑ready leveraging digital tools and AI‑enabled systems where appropriate to streamline data management. Mindsets We digitise everywhere possible using the power of code to maximise our impact on patients. In this role, embracing Moderna’s digital‑first approach will be critical particularly in leveraging technology—including emerging Generative AI capabilities—to improve QMS documentation, data traceability and audit preparedness. We behave like owners. The solutions we build go beyond any job description. As the sole quality lead in Australia this role demands proactive ownership. You will drive foundational and strategic quality systems locally while influencing broader global compliance standards in a high‑growth innovative environment. Basic Qualifications Education: Bachelor’s Degree in a relevant scientific discipline (e.g., Pharmacy, Biology, Chemistry). Experience: Minimum 10 years of relevant experience in the pharmaceutical industry across quality, regulatory and pharmacovigilance functions. Certifications or Training: Qualification to act as an Authorized Person and Responsible Person. Other Preference: Experience supporting or leading regulatory inspections (TGA preferred); strong understanding of batch disposition and GDP‑compliant distribution; demonstrated ability to learn and apply evolving GxP regulations and lead cross‑functional implementation of compliant quality practices. This position is site‑based requiring you to be at Moderna’s site full‑time. This position is not eligible for remote work. As part of Moderna’s commitment to workplace health and safety this role may be subject to pre‑employment and periodic medical assessments in line with relevant legal and operational requirements. 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 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 recognised 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 to learn more about our current opportunities. Moderna is a smoke‑free, alcohol‑free and drug‑free work environment. Moderna is committed to equal opportunity in employment and non‑discrimination for all employees and qualified applicants without regard to a person’s race, colour, 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. #J-18808-Ljbffr