Qa Technical Operations Lead

**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 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.

As the QA Technical Operations Lead at Moderna's Resilience site in Melbourne, you will play a crucial role in maintaining the highest standards of quality and compliance for mRNA drug substances and sterile drug products. Reporting to the Site Quality Head, you will be a key player in a team that values innovation, quality, and efficiency. Your responsibilities will include overseeing quality assurance for manufacturing operations, technology transfer projects, and facility compliance, embodying a dynamic range of capabilities. This role is critical in ensuring that our groundbreaking mRNA technology continues to meet the rigorous standards required to transform medicine and improve patient outcomes worldwide.

**Here's What You'll Do**:Your key responsibilities will be**:
Provide Quality oversight for commissioning, qualification, and validation initiatives, including complex GMP facility or critical utility projects.

Oversee product Technology Transfers, ensuring compliance and quality standards.

Manage significant deviations, including root cause analysis records and change controls.

Review and approve protocols, risk assessments, facility changes, and/or control strategies.

Write, review, and approve GMP documentation (SOPs, Forms, Technical Reports, Specifications, etc.).

Participate in Internal and External Audits, including Health Authority inspections.

Collaborate cross-functionally to foster a Quality Culture and a continuous improvement mindset.

**Your responsibilities will also include**:
**The key Moderna Mindsets you'll need to succeed in the role**:
**Pivot Fearlessly**: Your role will require flexibility and resilience in the face of changing regulations and operational needs. Your ability to adapt and pivot in response to new data and challenges will be crucial.

**Question Convention**: You'll challenge the status quo and drive innovation in our QA processes, always looking for better, more efficient ways to achieve our quality goals.

**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+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices

Demonstrated ability making risk based decisions

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 Scie