Site Quality Head

The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening Australia’s biotech landscape through a long term partnership focused on pandemic resilience. Our Melbourne based mRNA vaccine manufacturing facility will support rapid response to future health threats while creating skilled jobs and developing local talent. We welcome professionals ready to help advance global health security. This is a senior Quality leadership opportunity at the heart of Moderna’s Manufacturing and Supply operations in Australia, with responsibility for end-to-end Quality Assurance across Drug Substance (DS) and Drug Product (DP) sterile manufacturing and Country Quality. As the senior-most Quality leader in Australia and Site Quality Head, you will shape and execute a multi-year Quality strategy, safeguard product quality and patient safety, and ensure a sustained state of GxP compliance and inspection readiness against TGA requirements, PIC/S Annex 1 and Moderna global standards. Leading the Clayton Quality Assurance organization, you will be the primary Quality business partner to the Site Head and Country General Manager and a strategic interface between Australian requirements, business goals and Moderna’s global Quality strategy. Your influence will extend across APAC, contributing to regional Quality strategy, new-market and site readiness, Quality risk management, new capabilities, evolving supply models and future network expansion. This role combines enterprise-level Quality strategy with hands-on operational leadership. You will have the authority and independent judgment to escalate, pause or stop GxP activities when product quality, patient safety or regulatory compliance may be impacted, while building a high-performing Quality organization equipped for Australia’s current operations and future APAC growth. You will also have opportunities to get close to Generative AI and emerging digital tools, exploring how they can strengthen Quality insights, organizational learning, risk identification and the effectiveness of Quality operations within appropriate GxP frameworks. Here's What You'll Do: Serve as the senior-most Quality leader in Australia, with overall accountability for the Quality strategy, compliance state and Quality performance of Australia Manufacturing and Supply, including site-level GxP compliance, inspection readiness and performance of the Quality Management System (QMS). Provide strategic leadership to the Clayton Quality Assurance organization supporting Drug Substance and Drug Product sterile manufacturing operations, building a strong Quality culture while maintaining a consistent QA presence on the manufacturing floor and at CMOs. Develop and execute a multi-year Quality strategy for Australia Manufacturing and Supply aligned with site, country, APAC and Global Quality priorities. Contribute to and help shape APAC Quality strategy, including the Quality operating model, regional risks, future capabilities and expansion priorities. Lead Quality readiness for new markets, sites, capabilities and supply models within Australia and, as appropriate, across APAC, ensuring Quality and regulatory requirements are incorporated early into business and network planning. Provide Quality leadership and risk assessment for regional growth and expansion, identifying emerging compliance, regulatory, supply and product-quality risks and ensuring appropriate mitigation and escalation. Serve as the primary Moderna Quality representative to relevant GxP government agencies, including the Therapeutic Goods Administration (TGA), leading responses to TGA and other health authority inspections, interactions and communications. Oversee the Authorized Person and Country Quality Representative responsible for market release, ensuring robust systems and compliance with TGA requirements. Act as the senior Quality decision-maker for Australia Manufacturing and Supply, with authority to escalate, pause or stop GxP activities where product quality, patient safety or regulatory compliance may be adversely impacted. Exercise independent Quality judgment and senior-level decision rights on significant compliance, product quality, inspection and business-continuity matters, escalating to Global Quality leadership where appropriate. Ensure compliance with sterile manufacturing expectations, including PIC/S Annex 1 and contamination control strategies. Ensure implementation and ongoing performance of robust Quality Systems, including Deviation Management, CAPA, Change Control, Training and Documentation. Represent Quality on the Site Leadership Team, the Australia commercial leadership team and in strategic country-level discussions, ensuring Quality considerations and risks inform key business, investment, network and expansion decisions. Actively connect and integrate the site Quality organization with the Global Quality network, ensuring Australia has a strong voice in global decision-making, shares and adopts best practices, and contributes to the development of global standards, strategies and priorities. Represent the interests and expectations of Australia Manufacturing and Supply Quality Assurance on the Global Manufacturing Quality Assurance Leadership Team and through interactions across Global Quality at Moderna. Represent Australia and contribute an APAC perspective in Global Quality discussions, identifying opportunities to harmonize Quality approaches across existing and emerging regional operations. Oversee training and development to maintain a qualified, capable and inspection-ready workforce. Monitor key Quality metrics, lead site-level Quality Management Reviews and proactively address opportunities for improvement in alignment with global and local expectations. Establish and maintain visibility of strategic Quality risks, trends and organizational health, ensuring material risks are effectively communicated to senior site, country and Global Quality leadership. Lead and mentor a high-performing Quality team through clear goal setting, coaching and development planning. Build organizational capability and leadership depth appropriate to current operations and future Australia/APAC growth, including developing Quality leaders and succession pipelines. Ensure the site maintains inspection readiness, robust contamination control strategies and operational excellence. Oversee the quality and compliant implementation of global initiatives at the site, including new product introductions and technology transfers, as well as Quality readiness associated with new technologies, capabilities, markets and network expansion. Identify and assign appropriate deputies to ensure business continuity during absences. Develop and execute succession planning and staff development initiatives. Foster a culture of quality, inclusion, continuous improvement and collaboration across the organization. Represent Moderna in industry working groups and external Quality forums as needed. Bring a digital-first perspective to Quality leadership, including opportunities to engage with Generative AI and emerging digital capabilities that can responsibly enhance insights, learning, decision support and operational effectiveness within the Quality organization. The key Moderna Mindsets you’ll need to succeed in the role: “We act with dynamic range, driving strategy and execution at the same time at every step.” “We behave like owners. The solutions we’re building go beyond any job description.” Here’s What You’ll Bring to the Table: Bachelor’s or Master’s degree in Sciences (Biology, Microbiology, Chemistry, Pharmacy) or Engineering, or equivalent combination of education and experience. 20+ years of pharmaceutical industry experience, with a strong focus on sterile manufacturing, GMP compliance, and Quality Assurance. Minimum 5 years in senior leadership roles with oversight of QA/QC teams. Demonstrated success in managing site-level and regulatory Quality operations. Experience interacting with health authorities including TGA. Familiarity with PIC/S, Annex 1 or equivalent compliance frameworks. Demonstrated ability to operate strategically across site, country and/or regional organizations, including Quality leadership supporting new capabilities, markets, network expansion or significant organizational growth. Excellent leadership, interpersonal, and cross-functional collaboration skills. Strong analytical and decision-making capabilities. Demonstrate aptitude or ability to learn in order to gain a strong understanding of evolving GxP regulations. 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. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Competitive healthcare, plus voluntary benefit programs to support your unique needs A holistic approach to well-being with access to fitness, mindfulness, and mental health support Family building benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown Savings and investments to help you plan for the future 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 leavesandaccommodations@modernatx.com.  #LI-AG2 -