Collaborate and partner with the local Australia Site, the BioNTainer QA organizations (Global and other Sites), and Quality organizations across BioNTech to ensure all regulations and procedures are followed as applicable for the Australia BioNTainer Facility.
Responsible for performing Technical QA for mfg and QA for QC activities for the Australia BioNTainer site.
Support shaping local processes and providing support to local and global stakeholders, including providing technical QA support for applicable procedures and processes developed and implemented for the site.
Supporting the implementation and set-up of the site, manufacturing and analytical equipment and systems, commissioning, pre-qualification/qualification/validation activities.
Supporting technology transfer (process and method), new product introduction, testing, specifications, and technical operations, as examples, for the site.
Support and provide technical QA input and guidance for deviations, investigations, and change controls; provide support during audits and inspections (internal and external).
Help to establish and maintain GMP/GDP compliance and contribute to regulatory submissions as appropriate.
Support the development and management of Quality metrics and continuous improvement initiatives for the site.

University degree (e.g., Bachelor’s degree) in relevant scientific discipline, and additional qualifications (MSc, MBA) are advantageous.
6-8+ years of relevant experience in pharmaceutical or Biotechnology industry (GMP/GDP).
Experience in sterile manufacturing, filling and packaging and labeling operations is advantageous.
Working knowledge of relevant regulations and guidelines (e.g., TGA, PIC/S, ICH), and additional experience with WHO, EMA, US FDA etc. are advantageous.
Experience with national or international regulatory agency and participation in hosting/supporting inspections is advantageous.
Quality Operations experience across pharmaceutical GMP/GDP functions (additional experience within a technical quality function) is desirable.
Ability to be agile, effectively collaborate, and build consensus in a dynamic, cross-functional environment.
Outstanding communication skills (English: verbal and written).

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base.
We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
The availability, eligibility and design of the listed benefits may vary depending on the location.
The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Manager, Technical QA

Key skills