Associate Director QA Operations & Systems QA
BioNTech
Location
Australia
Type
Full-time
Posted
Jan 15, 2026
Mission
What you will drive
Core responsibilities:
- Establish, maintain, and develop Quality Assurance (QA) Operations and Systems teams and processes for the Australia BioNTainer site
- Ensure implementation of GMP compliant operations and quality system at the site
- Help develop and ensure the Quality mindset of the organization and preserve compliance with national and international regulations
- Build, maintain, and develop a team of QA operations & systems experts
Impact
The difference you'll make
This role helps establish regional mRNA manufacturing facilities (BioNTainers) in Australia to improve healthcare accessibility worldwide, particularly for diseases with high medical needs like cancer and infectious diseases.
Profile
What makes you a great fit
Required qualifications:
- University degree (e.g., Bachelor's degree) in relevant scientific discipline, with additional qualifications (MSc, MBA) advantageous
- 8+ years of relevant experience in pharmaceutical industry with GMP/GDP experience
- Working knowledge of TGA and PIC/S relevant regulations and guidelines (experience with ICH, US FDA, EMA, etc. advantageous)
- Experience in hosting inspections and collaborating with national or international regulatory agencies
- Quality Operations experience across pharmaceutical GMP functions
- Experience within a quality organization supporting development of IMPs (vaccines, biologics and ATMPs) from early through late-phase clinical trials highly advantageous
Benefits
What's in it for you
BioNTech offers competitive remuneration packages determined by role, location, and candidate qualifications/experience. The company is committed to team member wellbeing and offers various benefits, though specific details vary by location and are subject to internal policies and applicable law.
About
Inside BioNTech
BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival, focusing on diseases with high medical needs like cancer and infectious diseases. They develop modular mRNA-manufacturing facilities called BioNTainers to improve healthcare accessibility worldwide.