Associate Director QA Operations & Systems QA

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

This role helps build a regional manufacturing network in Africa & Australia to make mRNA innovations accessible worldwide, improving healthcare globally by addressing diseases with high medical needs like cancer and infectious diseases.

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

BioNTech offers competitive remuneration packages determined by the specific role, location of employment, and the selected candidate's qualifications and experience. The company is committed to the wellbeing of team members and offers a variety of benefits in support of a diverse employee base.