Senior QA & Validation Lead, Tech Ops (GMP)

BioSpace; City of Melbourne; On-site; AUD 150,000 - 210,000; Full time

Benefits offered by this job

Healthcare benefits

Flexible work options

Paid parental leave

Job summary

Moderna Australia in Melbourne seeks a QA professional to ensure quality, compliance, and technical excellence of mRNA manufacturing operations.

You will work across manufacturing, validation, technology transfer, and quality systems, delivering inspection-ready operations and data-driven decisions.

The role emphasizes collaboration with Operations, MS&T, Engineering, QC, and Supply Chain, while advancing a strong quality culture.

Qualifications

• Bachelor's degree in a science or engineering discipline, or equivalent.
• 5+ years of pharmaceutical quality, validation, or GMP experience.
• Experience with equipment qualification and process validation in a GMP-regulated environment.
• Experience with deviations, investigations, CAPAs, change controls, and risk assessments.
• Experience supporting QC laboratory validations, investigations, and escalation in a GMP-regulated environment.
• Demonstrated risk-based decision making and strong technical writing for GMP and validation documentation.

Responsibilities

• Provide quality oversight across manufacturing operations and QC laboratory validation activities.
• Lead or support validation lifecycle activities including PPQ and CPV.
• Review validation documentation and risk assessments.
• Act as QA escalation point for issues.
• Support regulatory audits and inspection readiness.
• Collaborate with cross-functional teams to manage validation risks.

Skills

Quality oversight

Validation

GMP experience

Cross-functional communication

Technical writing

Audits & inspections support

Education

Bachelor's degree in science or engineering

Job description

Moderna Australia in Melbourne seeks a QA professional to ensure quality, compliance, and technical excellence of mRNA manufacturing operations.

You will work across manufacturing, validation, technology transfer, and quality systems, delivering inspection-ready operations and data-driven decisions.

The role emphasizes collaboration with Operations, MS&T, Engineering, QC, and Supply Chain, while advancing a strong quality culture.