Senior Specialist, On-the-Floor, Quality Assurance (Biotech)

Location: Melbourne, Australia; site-based and full-time onsite. This position is not eligible for remote work.

Company

hirify.global develops mRNA medicines, vaccines, and therapeutics through its mRNA technology, delivery, and manufacturing platform.

What you will do

• Provide real-time QA oversight across cGMP manufacturing operations and QC laboratories, including walkthroughs, batch record review, laboratory documentation review, and verification of facility and contamination-control practices.
• Make risk-based quality decisions, communicate quality concerns, and escalate risks affecting product quality, patient safety, compliance, or operational continuity.
• Manage and oversee deviations, OOS and OOT investigations, laboratory non-conformances, CAPAs, change controls, and quality risk management activities.
• Review, author, and approve SOPs, work instructions, protocols, reports, APQR inputs, technical assessments, and other GMP documentation.
• Support QC systems and activities including microbiology, environmental monitoring, clean utilities, stability programs, analytical method lifecycle management, data trending, and contract laboratory oversight.
• Support inspection readiness, coach Manufacturing and QC personnel, collaborate with global QA teams, and contribute to digital quality and AI-enabled improvement initiatives.

Requirements

• Bachelor’s degree in a science-related field such as Biology, Microbiology, Chemistry, Pharmacy, or Engineering, or an equivalent combination of education and experience.
• At least 5 years of pharmaceutical, biopharmaceutical, or related experience with an emphasis on current Good Manufacturing Practices.
• Working knowledge of Quality Systems and electronic systems such as SAP, LIMS, MODA, eLN, CDS, electronic batch records, or similar platforms.
• Strong knowledge of cGMP regulations, ISO standards, data integrity, regulatory guidance, deviations, CAPAs, risk assessments, and quality investigations.
• Experience with QA on-the-floor support, QC laboratories, analytical or microbiological method lifecycle activities, and regulatory inspections or audits.
• Full-time onsite work at the hirify.global Melbourne site is required; remote work is not available. Pre-employment and periodic medical assessments may apply.

Nice to have

• Experience with QC microbiology, environmental monitoring, clean utilities, contamination control, laboratory controls, and health authority inspections.
• Leadership, coaching, communication, project management, and organizational skills.
• Experience implementing digital quality technologies, analytical tools, or AI-enabled quality solutions.

Culture & Benefits

• Benefits and well-being resources are designed to support employees at work and at home.
• Benefits vary according to employment conditions and the country of work.
• Work within a global quality and manufacturing network focused on learning, ownership, collaboration, and continuous improvement.
• Contribute to a mission focused on developing transformative mRNA medicines for patients.