QA Technical Operations Lead

at  Moderna

HERE’S WHAT YOU’LL BRING TO THE TABLE:

Bachelor’s Degree in a science field (e.g., Engineering, Chemistry) or equivalent combination of education and experience
8 – 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
Demonstrated ability making risk based decisions
Sterility Assurance experience
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
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, and a discretionary year-end shutdown
Educational resources
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 employment opportunity 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 also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations 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 .

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 is set to be a cornerstone in Australia’s response to future health threats. This initiative emphasizes not only the forefront of medical technology but also the development of local talent and job creation. We invite visionary professionals to join us in this transformative journey, making a tangible impact on global health security.
Elevate Your Career at Moderna as the QA Technical Operations Lead in Australia. Reporting to the Site Quality Head, this role is integral in supporting cGMP mRNA drug substances and sterile drug product production. The successful candidate will provide quality oversight of manufacturing operations, technology transfer projects, and other GMP facility aspects, showcasing a dynamic range of capabilities.
Here’s What You’ll Do:Your key responsibilities will be:
Providing quality oversight for commissioning, qualification, and validation initiatives, including GMP facility or critical utility projects.
Overseeing product Technology Transfers and significant deviations, including root cause analysis records, and change controls.
Owning the site Contamination Control Strategy and program, ensuring adherence to Sterile Manufacturing requirements.

YOUR RESPONSIBILITIES WILL ALSO INCLUDE:

Reviewing and approving various protocols, risk assessments, facility changes, and control strategies.
Writing, reviewing, and approving GMP documentation such as SOPs, Forms, Technical Reports, and Specifications.
Engaging in internal and external audits, including Health Authority inspections.

THE KEY MODERNA MINDSETS YOU’LL NEED TO SUCCEED IN THE ROLE:

Pursuing options in parallel: This mindset is critical in your role as you manage multiple quality initiatives and projects simultaneously. It ensures efficiency and optimal decision-making by evaluating various strategies side by side, particularly during technology transfers and the implementation of new quality systems. Your ability to multitask effectively while maintaining high standards in all processes will be crucial.
Acting with urgency: In the fast-paced environment of pharmaceutical manufacturing, the urgency with which you handle quality oversight can significantly influence the speed at which new and safe medications reach patients. Your role involves rapid response to quality issues, swift validation of processes, and expedient handling of deviations and corrective actions. This urgency is vital not only to compliance but to the broader goal of enhancing public health outcomes through timely delivery of our products.