Senior Specialist, On-the-Floor, Quality Assurance

Location: Melbourne, Australia; site-based and not eligible for remote work

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 real-time QA oversight across manufacturing operations and QC laboratories supporting cGMP mRNA drug substance production.
• Conduct walkthroughs and review manufacturing, laboratory, batch record, and GMP documentation practices.
• Manage and oversee deviations, OOS/OOT investigations, root cause analysis, risk assessments, change controls, and CAPA activities.
• Provide QA oversight of QC systems, microbiology, environmental monitoring, clean utilities, contamination control, stability programs, and data integrity.
• Support method qualification, validation, transfer, lifecycle management, external laboratory governance, and regulatory inspections including TGA inspections.
• Coach Manufacturing and QC personnel and contribute to digital quality transformation and AI-enabled quality solutions.

Requirements

• Bachelor’s degree in a science field such as Biology, Microbiology, Chemistry, Pharmacy, or Engineering, or equivalent experience.
• At least 5 years of pharmaceutical, biopharmaceutical, or related experience with a focus on cGMP.
• Working knowledge of Quality Systems and electronic systems such as SAP, LIMS, MODA, eLN, CDS, or electronic batch records.
• Strong knowledge of cGMP regulations, data integrity, ISO standards, and relevant regulatory guidance.
• Experience with QA on-the-floor support, QC laboratories, deviations, CAPAs, OOS/OOT investigations, risk assessments, or digital quality systems.
• Full-time presence at the hirify.global site in Melbourne is required; remote work is not available.

Nice to have

• Experience with regulatory inspections or audits as a subject matter expert.
• Experience with analytical or microbiological method validation, transfer, qualification, or lifecycle management.
• Understanding of QC microbiology, environmental monitoring, clean utilities, contamination control, and laboratory controls.
• Leadership, coaching, communication, project management, and organizational skills.

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, recharge days, and year-end shutdown.
• Savings and investment programs plus location-specific benefits.
• In-person collaboration supported by a 70/30 work model.