Associate Director, Quality Control

5 months ago

Melbourne, Australia Moderna Full time

**The Role**:
Moderna is on the lookout for a dynamic, motivated, and dedicated professional to serve as the Associate Director for Quality Control at our new manufacturing site in Australia. The individual in this role will directly oversee commercial testing functions in the Quality Control department in support of raw materials and drug substances testing for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations (this will include Microbiological and EM tests as well). Also, this individual may support related method transfer, qualification and validation activities and assist in the development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements. He/she will also manage a group of laboratory personnel and oversee performance management, mentoring and career development. The individual will act as interdepartmental liaison to various groups including AS&T, Global QC, External QC, Quality Assurance and Regulatory.

**Here's What You’ll Do**:
Oversees day-to-day operations of the Quality Control commercial program testing functions, including stability.

Ensure on time delivering of tests results and proper support of deviations.

Work with a Lean mindset and suggest any change that can improve the efficiency.

Manages laboratory personnel and oversees their selection, performance management, mentoring, and career development.

Assists in development of appropriate Standard Operating Procedures, laboratory data collection & documentation systems (paper and electronic) and training of personnel to ensure cGMP compliance.

Supports laboratory investigations, change controls, and CAPAs for relevant QC operations.

Contributes to budget planning and resource allocation.

Provide testing data and other required quality-related information needed to support product studies.

Interacts with AS&T, Quality Assurance, Regulatory Affairs, and other Departments to:
Support testing for drug substance and drug product internally and at CMOs and contract laboratories.

Provide testing data and other required quality-related information needed to support stability programs, APQR.

Collaborates/Supports with AS&T and development groups for method transfer and qualification activities as required.

Assists in development, implementation, and maintenance of general laboratory operational QC/IT systems in accordance with cGMP requirements.

Interface with health authorities to support site and external inspections as required.

Troubleshoots issues related to laboratory procedures and assay performance.

Provides support to audit teams for Health authority, Internal/External and vendor audits.

Ensures teams perform tasks as needed to maintain GMP compliance

Evaluate, align, and oversee QC data analytics, monitoring, and trending (e.g., method and product performance trending).

Works with Digital/IT to continually strengthen data integrity across the QC testing laboratories.

**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

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