Principal Specialist QA Tech Ops at Moderna

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

04 Oct, 26

Salary

0.0

Posted On

06 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Oversight, Equipment Qualification, Process Validation, Lifecycle Validation Management, Analytical Method Validation, Quality Risk Management, GMP Compliance, Technical Writing, Cross-functional Communication, Audit Readiness, Deviation Management, CAPA, Change Control, Technology Transfer, QC Laboratory Support, Sterile Drug Product Manufacturing

Industry

Biotechnology Research

Description

The Role 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. Reporting to the Site Quality Head, this role provides quality oversight across manufacturing operations, technology transfer activities, GMP facility initiatives, and QC laboratory-related quality support, with primary focus on drug product validation, including equipment qualification, process validation, lifecycle validation management, analytical method validation and associated laboratory validation support. The successful candidate will bring strong experience in pharmaceutical quality oversight within commercial manufacturing environments and demonstrate the ability to apply quality risk management principles to support compliant and efficient operations. This individual will serve as a key quality partner to Operations, MS&T, Engineering, Facilities, QC, Supply Chain, and other Quality functions, ensuring that validation and manufacturing activities are scientifically sound, inspection-ready, and aligned with site and global quality system requirements. Here’s What You’ll Do Provide quality oversight for commissioning, qualification, and validation activities associated with drug product manufacturing equipment, systems, facilities, and critical utilities. Support and provide QA oversight for the process validation lifecycle, including validation strategy, process performance qualification, continued process verification, and changes impacting validated state. Provide quality oversight for QC laboratory-associated validation activities, including equipment qualification, laboratory systems changes, and other validation-related activities that may impact product quality or validated state. Support and/or lead quality review of QC laboratory investigations, deviations, CAPAs, and change controls, ensuring issues are appropriately assessed, escalated, and resolved in a timely and scientifically sound manner. Act as a key QA escalation point for technical, operational, and QC laboratory validation or investigation issues, supporting timely issue resolution and sound, risk-based decision making. Review and approve validation documentation, including protocols, reports, discrepancy assessments, change controls, and risk assessments, ensuring records are scientifically sound, timely, and aligned with site and global quality system requirements. Provide quality oversight for product technology transfers, process implementation activities, and technical changes impacting drug product manufacturing processes, validated systems, or associated QC laboratory activities. Ensure manufacturing and associated support activities are executed in accordance with approved procedures, validated process parameters, equipment qualification requirements, and established control strategies. Lead or support quality review of deviations, investigations, CAPAs, and change controls related to validation, technical operations, manufacturing processes, and QC laboratory support activities. Partner closely with Operations, Facilities, MS&T, QC, Engineering, Supply Chain, and Quality to proactively identify, assess, and manage validation, process, laboratory, and compliance risks across site activities. Apply quality risk management tools and principles to support technical assessments, change evaluations, deviation investigations, escalation decisions, and actions affecting product quality or validated state. Review and approve GMP documentation such as SOPs, forms, technical reports, specifications, validation protocols, validation summary reports, and associated records. Support and undertake quality review activities associated with GMP release of materials and/or batch disposition, as applicable. Serve as a key contributor to inspection and audit readiness, including internal audits, client audits, and regulatory inspections. Lead or support drafting of inspection and audit responses, and the development and implementation of remediation actions arising from observations related to technical operations, validation, QC laboratory support, and manufacturing controls. Conduct routine floor presence and quality oversight to confirm adherence to approved procedures, GMP requirements, validated operating practices, and documentation expectations. Coach operations and support personnel on validation principles, documentation practices, investigation quality, and risk-based quality expectations to strengthen operational execution and quality culture. Support the ongoing improvement of validation systems, technical quality processes, laboratory quality support, and operational readiness programs to enhance compliance, robustness, and efficiency. Support the training and development of QA team members and contribute to building technical capability across the function. Play a critical role in ensuring the overall quality and compliance of Moderna's manufacturing operations in Australia through strong technical judgment, collaboration, and visible QA leadership. Here's What You'll Need (Basic Qualifications) Bachelor's degree in a science or engineering discipline, or equivalent combination of education and experience. 5+ years of pharmaceutical quality, validation, or related GMP experience. Experience with equipment qualification, process validation, and validation lifecycle management in a GMP-regulated environment. Experience with deviations, investigations, CAPAs, change controls, and risk assessments. Experience supporting QC laboratory validations, investigations, and escalation in a GMP-regulated environment. Demonstrated risk-based decision making and strong technical writing for GMP and validation documentation. Strong cross-functional communication skills, with experience supporting audits and inspections. Here's What You'll Bring to the Table (Preferred Qualifications) Experience supporting sterile drug product manufacturing. Experience with process performance qualification, continued process verification, and drug product equipment qualification. Experience supporting QC laboratory equipment qualification and GMP laboratory quality systems. Experience applying formal quality risk management methodologies to process, equipment, system, or laboratory changes. Experience supporting technology transfer, startup, or commissioning in a highly regulated manufacturing environment. 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. - 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

Provide quality oversight for commissioning, qualification, and validation activities across drug product manufacturing and QC laboratories. Act as a key QA partner to ensure operations are scientifically sound, inspection-ready, and aligned with global quality systems.