Team Lead, Quality Control, Raw Materials & Environmental Monitoring at Moderna

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

02 Aug, 26

Salary

0.0

Posted On

05 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, cGMP, Environmental Monitoring, Raw Materials Testing, Team Leadership, CAPA, Change Control, Analytical Data Review, SOP Authoring, Regulatory Audit Readiness, Stakeholder Management, Operational Excellence, Critical Utilities Management, Investigation Execution, Risk Mitigation, Method Transfer

Industry

Biotechnology Research

Description

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 its presence in Melbourne, a leading biotech hub in Australia. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global professionals committed to making a meaningful impact. Reporting to the Associate Director of Quality Control, you will lead critical QC operations overseeing raw materials, environmental monitoring, and critical utilities within a cGMP environment. You will operate at the intersection of quality, manufacturing, and innovation enabling compliance while enabling the speed and scale of mRNA production. This afternoon-shift leadership role offers the opportunity to drive operational excellence, mentor high-performing teams, and contribute to next-generation digital and AI-enabled quality systems. Here's What You'll Do: Lead, coach, and develop a team of QC analysts, fostering an inclusive, high-performance culture grounded in accountability and continuous learning. Oversee raw material and consumable sampling and testing activities, ensuring full compliance with cGMP and global regulatory requirements. Coordinate and optimize scheduling and prioritization of QC testing activities to meet dynamic production timelines. Manage Environmental Monitoring (EM) and Critical Utilities (CU) programs, including sampling, testing, data trending, and reporting. Ensure compliant and efficient shipment of samples to external laboratories, maintaining regulatory and quality standards. Review and approve analytical data within electronic laboratory systems, ensuring accuracy, completeness, and data integrity. Lead timely execution of investigations, deviations, CAPAs, and change controls, consistently meeting KPI expectations. Identify operational risks proactively and implement robust mitigation strategies to ensure uninterrupted quality operations. Collaborate cross-functionally with Manufacturing, Quality Assurance, MS&T, and external partners to ensure seamless operations. Author, review, and approve SOPs and work instructions, ensuring documentation remains current and compliant. Support regulatory inspections and audits, acting as a subject matter expert for raw materials, EM, and CU programs. Drive continuous improvement initiatives, leveraging digital tools and emerging technologies—including opportunities to integrate AI-driven insights—to enhance efficiency and compliance. Ensure strict adherence to safety, quality, and documentation standards across all QC activities. Support method transfers, validation, and qualification activities as required to enable process scalability and robustness. Provide flexible support across broader QC functions to meet evolving operational needs within Moderna’s manufacturing environment. Operate effectively on an afternoon shift, ensuring extended coverage for manufacturing and QC activities. The key Moderna Mindsets you’ll need to succeed in the role: “We act with urgency; Action today compounds the lives saved tomorrow.” “We digitize everywhere possible using the power of code to maximize our impact on patients.” Here’s What You’ll Need (Basic Qualifications) Bachelor’s degree in a relevant scientific discipline with 10+ years QC experience in a cGMP environment. Proven leadership experience with the ability to motivate, develop, and manage high-performing teams. Strong knowledge of environmental monitoring programs and raw material testing requirements. Demonstrated decision-making capability in a fast-paced, regulated environment. Proactive mindset with the ability to anticipate issues and drive solutions. Strong communication and stakeholder management skills. Passion for quality, continuous improvement, and operational excellence. Willingness to learn and adapt in a dynamic environment. Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment. Proven ability to conduct investigations. Experience with regulatory inspections and audit readiness. 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 global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class 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. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

Lead and develop a QC team overseeing raw materials, environmental monitoring, and critical utilities within a cGMP environment. Ensure operational compliance, manage analytical data integrity, and drive continuous improvement through digital and AI-enabled systems.