Associate Director, Quality Control

7 months ago

Melbourne, Australia Moderna Full time

**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, focusing on strengthening pandemic resilience. Our Melbourne-based large-scale mRNA vaccine manufacturing facility is set to be a key player in Australia's response to future health threats. This collaboration emphasizes not only cutting-edge medical technology but also job creation and local talent development. We invite visionary professionals to join us on this transformative journey and make a tangible impact on global health security.

Moderna is seeking an Associate Director for Quality Control at our new manufacturing site in Melbourne, Australia. This role involves overseeing commercial testing functions in the Quality Control department, supporting raw materials and drug substances testing, including microbiological and environmental monitoring tests. The role includes managing laboratory personnel and acting as an interdepartmental liaison, contributing significantly to our quality control and assurance operations.

**Here's What You’ll Do**:
Within 3 Months, You Will

Oversee the day-to-day operations of the Quality Control commercial program testing functions, including stability testing.

Ensure timely delivery of test results and provide efficient support for deviations.

Start implementing Lean methodologies to enhance efficiency in the QC processes.

Within 6 Months, You Will

Manage laboratory personnel, focusing on performance management, mentoring, and career development.

Assist in the development of Standard Operating Procedures and laboratory data systems to ensure cGMP compliance.

Support laboratory investigations, change controls, and CAPAs related to QC operations.

**Within 12 Months, You Will**:
Contribute to budget planning and resource allocation for the Quality Control department.

Provide essential testing data and quality-related information to support product studies and stability programs.

Collaborate with other departments, such as AS&T, Quality Assurance, and Regulatory Affairs, for method transfer and qualification activities.

**Here’s What You’ll Bring to the Table**:
**Minimum education required**: Bachelor’s Degree in a relevant scientific discipline.

**Minimum experience required**: 10 + years in applied industry experience; 4-6 years of management/supervisory experience.

Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs.

Previous supervisory experience is preferred, including testing scheduling and lab project management.

**Minimum knowledge required**: general laboratory operations, method acquisition, qualification.

**Minimum skills required**:
Technical writing.

Proficiency with Microsoft Office Programs.

Familiarity with electronic databases (e.g., LIMS, SAP, LMS).

Familiarity with QC operations including bioassay, chemistry, and microbiology.

HPLC Instrumentation/ Software experience is preferred.

Strong written and oral communication skills as well as organizational skills.

Knowledge of industry standards and guidelines, experience supporting compliance audits.

Demonstrated ability to work effectively under established guidelines and instructions.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

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 tec

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