Manager Operations & Systems QA

Core responsibilities:

• Close collaboration and partnership with Global QA BioNTainer Set-up & Support Team, AUS Quality organization, and Quality organizations across BioNTech to ensure regulatory compliance in Australia
• Implement and set-up local GMP standards and procedures, quality systems, documentation control, training, metrics, audits and inspections
• Help establish and develop fit-for-purpose QA Operations and Systems processes ensuring GMP compliance and performing QA operations and systems activities for the site
• Provide general manufacturing and disposition support including batch records, CoA, EM, TEs, line clearance, CC, deviations and investigations, and documentation support

This role helps establish regional mRNA manufacturing facilities in Australia to improve global healthcare accessibility, particularly for diseases with high medical needs like cancer and infectious diseases.

Required qualifications:

• University degree (Bachelor's) in relevant scientific discipline, with additional qualifications (MSc, MBA) advantageous
• 6-8+ years of relevant experience in pharmaceutical industry GMP/GDP
• Working knowledge of relevant regulations and guidelines (TGA, PIC/S, ICH), with additional experience with WHO, EMA, US FDA advantageous
• Quality Operations experience across pharmaceutical GMP functions, with sterile manufacturing and filling operations experience highly advantageous

BioNTech offers competitive remuneration packages determined by role, location, and candidate qualifications and 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.

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival, with a focus on improving global health through innovations like mRNA manufacturing facilities called BioNTainers.