About this role
BioNTech
About the Role
In this exciting position, you will play a pivotal role in establishing and developing the Technical Quality Assurance (QA) organization and processes for our BioNTainer site in Australia (BTR-AUS) Your expertise will ensure GMP compliance and oversee Technical QA activities for manufacturing (MFG) and QC, supporting the site’s implementation, equipment setup, technology transfer, qualification/validation activities, and more You will also help foster a strong Quality mindset within the organization while maintaining compliance with national and international regulations This role offers a unique opportunity to contribute to BioNTech’s mission of pioneering individualized immunotherapies on a global scale
Your Contribution:
- Collaborate closely with the local BTR-AUS site, BioNTainer QA organizations (global and other sites), and wider Quality teams to ensure adherence to all relevant regulations and procedures
- Establish and develop a fit-for-purpose Technical QA structure for Manufacturing and QC in Australia, driving continuous improvement
- Lead, mentor, and manage the Technical QA team(s) while optimizing resource allocation for the site
- Support the creation and implementation of GMP standards and procedures tailored to the Technical QA organization at BTR-AUS
- Provide technical QA input for key activities such as equipment setup, technology transfer, qualification/validation processes, method/process validation, deviations, investigations, change controls, audits, and inspections
- Author GMP-compliant documentation (e.g., SOPs), contribute to regulatory submissions, Annual/PQ Reviews as applicable, and Management Reviews
- Develop and manage Quality metrics for the site while supporting Quality Council operations alongside internal (local/global) and external stakeholders
- Deliver hands-on leadership by training staff and fostering an interactive team environment
A Good Match:
- Bachelor’s degree in a relevant scientific discipline; advanced qualifications (PhD, MSc, MBA) are advantageous
- 8+ years (Associate Director) or 10+ years (Director) of significant experience in pharmaceutical GMP functions
- Expertise in sterile dosage forms, early-phase platforms, RNA/biologics production is advantageous
- Familiarity with TGA/PIC/S regulations; knowledge of ICH, US FDA, EMA guidelines is a plus
- Experience with regulatory inspections/audits on national or international levels
- Strong solution-driven mindset with excellent interpersonal skills
- Strong ability to conceptualize complex processes in fast-paced environments while navigating ambiguity
- Proven leadership experience managing teams/budgets effectively
- Outstanding verbal/written communication skills with an ability to build consensus across cross-functional teams
- Willingness to travel
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.
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.
Identity and Values:
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!
BioNTech - As unique as you