Senior Specialist, Supply Chain Compliance at Moderna

Melbourne, Victoria, Australia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

University degree in biology, chemical, or equivalent preferred
5+ years’ experience in Supply Chain or Warehousing including Audit Management, SOP Revisions, and working with SAP in a Pharmaceutical and Biotech manufacturing environment

Responsibilities

Managing compliance documentation to support efficient inbound and outbound processes
Reviewing SOPs for site Warehouse functions to ensure ongoing compliance and operational excellence
Revising training modules for local supply chain associates in collaboration with the Supply Chain Director
Supporting warehouse specialists by managing documentation for cycle counting and peaking activities
Handling documentation for sample movements in alignment with company standards
Managing deviations within the warehouse, working closely with the Warehouse Operations Lead and QA/QC team
Overseeing GMP requirements for the warehouse, proposing actionable steps for ongoing GMP readiness and compliance
Conducting export control for outbound shipments abroad, ensuring regulatory compliance
Monitoring and managing alarms (e.g., freezer alarms), addressing deviations as required
Engaging with cross-functional teams in a matrix organization to ensure seamless collaboration and high operational standards
Leveraging digital tools such as SAP, Smartsheet, Microsoft Word, and Excel to enhance workflow efficiency
Supporting the supply chain’s continuous improvement efforts with a proactive, customer-focused attitude
Performing additional duties as assigned to support Moderna’s supply chain objectives

Skills

Key technologies and capabilities for this role

GMPSOP ReviewWarehouse ComplianceSupply Chain ComplianceRegulatory ComplianceTraining ModulesDocumentation Management

Questions & Answers

Common questions about this position

What is the work location for this role?

The role is based at Moderna's Clayton office in Australia, focusing on supporting manufacturing and supply chain operations.

What are the main responsibilities in this position?

Key responsibilities include managing compliance documentation, reviewing SOPs, revising training modules, handling documentation for cycle counting and sample movements, managing deviations, overseeing GMP requirements, conducting export control, and monitoring alarms.

What tools or systems will I use in this role?

You will leverage digital tools such as SAP, Smartsheet, Microsoft Word, and Excel to enhance workflow efficiency.

What is the company culture like at Moderna?

Moderna offers a pioneering team environment revolutionizing medicine through mRNA technology, working alongside exceptional colleagues and strategic partners worldwide in a continually growing organization with a focus on global health initiatives.

What makes a strong candidate for this role?

A strong candidate will have expertise in GMP standards, supply chain compliance, SOP review, deviation management, and experience with digital tools like SAP, along with the ability to collaborate in a matrix organization.

Is this a remote position?

This information is not specified in the job description.

What is the salary for this position?

This information is not specified in the job description.

Moderna

Develops mRNA-based medicines for health

About Moderna

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treating diseases. Unlike traditional pharmaceuticals, which often rely on chemical compounds, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to improve patient outcomes by harnessing the power of mRNA to create effective treatments.

Cambridge, MassachusettsHeadquarters

2010Year Founded

$5,925.5MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

5,001-10,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

Sabbatical Leave

Hybrid Work Options

401(k) Company Match

Parental Leave

Family Planning Benefits

Fertility Treatment Support

Adoption Assistance

Wellness Program

Mental Health Support

Phone/Internet Stipend

Home Office Stipend

Risks

Potential backlash in Australia for bypassing vaccine safety steps.

Possible removal from Nasdaq 100 Index could affect investor confidence.

Hong Kong residents' reluctance to get vaccinated may hinder market penetration.

Differentiation

Moderna is pioneering mRNA technology for new categories of medicines.

The company integrates AI to optimize mRNA design and production processes.

Moderna's mRNA platform enables rapid development of vaccines and therapeutics.

Upsides

Moderna received a $176 million contract for a bird flu vaccine.

The company is expanding mRNA applications to personalized cancer vaccines.

Moderna is establishing a domestic mRNA production facility in Australia.

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