Principal Specialist QA Tech Ops (mRNA)

Location: Melbourne, Australia; 70% in-office work model

Company

hirify.global develops mRNA medicines and operates a technology platform focused on transforming how medicines are created and delivered.

What you will do

• Provide QA oversight across commercial GMP manufacturing, technology transfer, facility initiatives, and QC laboratory activities.
• Lead drug product validation activities, including equipment qualification, process validation, lifecycle validation management, analytical method validation, and laboratory validation.
• Review and approve validation protocols, reports, risk assessments, SOPs, specifications, change controls, deviations, CAPAs, and other GMP records.
• Act as a QA escalation point for technical, operational, validation, and QC laboratory issues using risk-based decision-making.
• Support GMP material release, batch disposition, audits, regulatory inspections, inspection responses, and remediation actions.
• Coach cross-functional teams and improve validation systems, technical quality processes, laboratory support, compliance, and operational readiness.

Requirements

• Bachelor’s degree in a science or engineering discipline, or equivalent education and experience.
• 5+ years of pharmaceutical quality, validation, or related GMP experience.
• Experience with equipment qualification, process validation, and validation lifecycle management in a GMP-regulated environment.
• Experience managing deviations, investigations, CAPAs, change controls, risk assessments, and QC laboratory validation activities.
• Strong technical writing, risk-based decision-making, cross-functional communication, and audit or inspection support experience.
• Ability to work in Melbourne, Australia, under the 70/30 in-office work model.

Nice to have

• Experience with sterile drug product manufacturing.
• Experience with process performance qualification, continued process verification, and drug product equipment qualification.
• Experience with QC laboratory equipment qualification and formal quality risk management methodologies.
• Experience supporting technology transfer, startup, or commissioning in a highly regulated manufacturing environment.

Culture & Benefits

• Healthcare and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family-building benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific benefits.
• In-person collaboration supported through a 70/30 work model.