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QA Operations Head

7 months ago

Melbourne, Australia Moderna Full time

The Role

Here’s What You’ll Do

**Manage a team of QA professional responsible for**: On-the-Floor manufacturing oversight, Deviation Management, Change Management, Batch Record Review and Product Disposition. Demonstrate dynamic range with the capability to also directly support these expectations.

Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.

Monitor key quality system metrics and process indicators to ensure adherence to compliance and performance expectations. Engage in plant tiered governance that supports performance expectations that includes quality, delivery, and safety.

Role model Quality Culture and the Moderna Mindsets. Collaborate closely with cross-functional partners and as an active member of leadership.

Support the training and development of the QA team including coordination of training, capability assessment and enhancement, and professional development.

Author, review and/or approve documentation, including SOPs, to ensure compliance and adherence to regulations/cGMP operations.

Be a champion for continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations. Utilize knowledge to improve operational efficiency.

Interface directly with Government or other regulatory authorities and ensure Moderna is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities. Ensure inspection readiness and provide guidance and support relative to Good Manufacturing Practices (GMPs).

Here’s What You’ll Need (Minimum Qualifications)

Bachelor’s Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, etc.) 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

Sterile drug product manufacturing experience preferred

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.

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 proud to be an equal opportunity workplace and is an affirmative action employer.

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. Moderna is an E-Verify Employer in the United States. 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.