Site Quality Head (Biotech)

Location: Melbourne, Australia; site-based full-time with no remote work

Company

hirify.global develops mRNA medicines and operates a Melbourne manufacturing facility focused on mRNA vaccines and pandemic resilience.

What you will do

• Lead the Australia Quality Assurance organization supporting sterile Drug Substance and Drug Product manufacturing.
• Own the site and country Quality strategy, compliance state, inspection readiness, and Quality Management System performance.
• Represent hirify.global in interactions with the Therapeutic Goods Administration and other relevant GxP authorities.
• Oversee market release, Quality risk management, contamination control, deviations, CAPA, change control, training, and documentation systems.
• Shape APAC Quality strategy and support new markets, sites, capabilities, supply models, product introductions, and technology transfers.
• Develop a high-performing Quality organization through mentoring, succession planning, capability building, and continuous improvement.

Requirements

• Bachelor’s or Master’s degree in Biology, Microbiology, Chemistry, Pharmacy, Engineering, or equivalent experience.
• 20+ years of pharmaceutical industry experience focused on sterile manufacturing, GMP compliance, and Quality Assurance.
• At least 5 years of senior leadership experience overseeing QA/QC teams.
• Experience managing site-level and regulatory Quality operations and interacting with health authorities, including TGA.
• Familiarity with PIC/S Annex 1 or equivalent compliance frameworks, GxP regulations, and contamination control strategies.
• Must work at hirify.global’s Melbourne site full-time; the position is not eligible for remote work.

Culture & Benefits

• Healthcare coverage and voluntary benefits.
• Fitness, mindfulness, and mental health resources.
• Family-building support, including fertility, adoption, and surrogacy benefits.
• 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 by hirify.global’s 70/30 work model.