Site Quality Lead
5 months ago
**The Role**:
Reporting to the Global Quality Head Commercial Drug Product with dotted-line reporting to the Global Quality Heads of Drug Substance and Quality Control, the Site Quality Head will be responsible for providing leadership and oversight in quality assurance for Moderna’s Drug Substance and Drug Product operations at the Australia manufacturing site. In addition, the Site Quality Head will have responsibility for the Quality Control laboratory performing chemistry and microbial testing.
This leadership role will ensure robust processes and systems that meet compliance requirements and support the delivery of high-quality mRNA product for the local market or export. As a member of the Site Leadership Team, the Quality Head will drive a strong quality culture, deliver on production and testing commitments, and closely monitor performance.
**Here’s What You’ll Do**:
Establish and lead an organization responsible for supporting internal Drug Substance and Drug Product manufacturing operations as well as technology transfers and CQV at Moderna’s Australia site. Ensure the site operates in compliance with regulatory and GMP expectations to sustainably deliver high quality product.
Ensure quality policies, procedures, and training are understood and implemented for the site as well as supportive programs and strategies including contamination control.
Review and approve cGMP documentation (Change Management, Deviation Management, Batch Records, Protocols, Specifications, Technical Reports, CAPAs, etc) and ensure alignment with global processes and platforms.
Ensure Quality Assurance presence on the manufacturing floor.
Ensure the robust and timely execution of Batch Disposition.
Establish and monitor key quality performance indicators to proactively identify and address quality system or product issues, and ensure stability, effectiveness, and improvement.
Routinely analyze and present the health of the organization for transparency and to drive accountability.
Establish and maintain a robust Quality Control laboratory able to meet business commitments. This should include testing execution as well as sample management, stability management, laboratory investigations, and performance monitoring.
Interface directly with TGA 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).
Design, build, and continuously develop a high-functioning Quality organization connected with the company’s strategic goals and quality objectives.
Role model Quality Culture and the Moderna Mindsets
Contribute as an active and engaged member of the site leadership team as well as global Quality leadership teams
Coach and mentor direct reports and others across the QA organization and site
Champion continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations.
Develop resource strategies, allocate budget, and assess / build capabilities necessary to support effective and efficient operations.
Additional duties as may be assigned.
**Here’s What You’ll Bring to the Table**:
Bachelor’s or Master’s degree, preferably in Sciences (Biology, Microbiology, Chemistry, Pharmacy) or Engineering, or equivalent combination of education and experience.
15+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices
Demonstrated ability to analyze complex issues and situations
Excellent leadership skills with the ability to operate independently, collaborate cross-functionally, and foster a positive culture
Previous experience with sterile Drug Product manufacturing and Quality Control, 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 peopl
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