Manager Operations & Systems QA

Responsibilities

• Ensure GMP compliance and perform Quality Assurance (QA) operations and systems activities for the BioNTainer site in Australia.
• Establish, maintain, and develop local QA operations, systems processes, and documentation control (change control, deviations, CAPA).
• Implement local GMP standards, training programs, metrics, and audit/inspection readiness processes.
• Collaborate with Global QA and local BioNTech teams to ensure alignment with national and international regulations.
• Provide manufacturing and disposition support, including batch records, CoA, and investigation oversight.
• Author QA procedures (SOPs) and contribute to regulatory submissions and quality reviews.
• Provide hands-on leadership, mentoring, and continuous improvement initiatives for the site.

Requirements

• University degree in a relevant scientific discipline.
• 6-8+ years of pharmaceutical industry experience in GMP/GDP environments.
• Working knowledge of TGA, PIC/S, and ICH regulations.
• Proven experience in Quality Operations within a pharmaceutical setting.
• Fluency in English (written and spoken) is essential.
• Ability to navigate ambiguity and manage tasks in a fast-paced, dynamic environment.

Preferred Qualifications

• Experience with sterile manufacturing and filling operations.
• Experience supporting the development of vaccines, biologics, or ATMPs through clinical phases.
• Experience hosting or supporting regulatory inspections.
• Advanced degrees such as an MSc or MBA.

Benefits

• Competitive remuneration packages based on role, location, and experience.
• A commitment to team member wellbeing and a diverse work environment.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are developing modular mRNA-manufacturing facilities called "BioNTainers" to make healthcare innovations accessible worldwide through regional manufacturing networks.