Manager Technical QA
Melbourne, Australia | full time | Job ID: 11056
About the role:
As Manager Technical QA, you will be responsible for helping to develop and maintain the Technical Quality Assurance processes, performing Technical QA for manufacturing and QC activities, and ensuring GMP/GDP compliance for the BioNTainer, Australia site, including: supporting the implementation and set-up of the site, manufacturing and analytical equipment and systems, commissioning and qualification/validation activities, technology transfer (process and method), new product introduction, and testing as examples.
Your contribution:
- Collaborate and 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.
A good match:
- 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).
What we do with the BioNTainers:
We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.
Benefits for you:
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.
Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: 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.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
We are looking forward receiving your application.