Specialist* QA (Operations & Compliance)

Become a member of the BioNTech Family!

Who we are:
We are a global immunotherapy company. Our 4,000+ colleagues globally are committed to improving the health of people worldwide with our fundamental research utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We leveraged our mRNA technology to develop a COVID-19 vaccine which became the first mRNA drug approved for human use.
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”.  The aim is to build a regional manufacturing network in Africa, with Africa, for Africa.
Why we need you:
The BioNTainers will be equipped to produce a range of mRNA-based vaccines targeted towards the needs of African Union member states. You will become part of the regional staffing team, driving the establishment of the regional African end-to-end mRNA manufacturing network.


Specialist* QA (Operations & Compliance)

Responsible for ensuring GMP compliance and performing Quality Assurance (QA) Operations activities for the Rwanda (RWA) BioNTainer site. This role will also be responsible for helping to establishing, maintaining, and developing QA Operations processes and develop and ensure the Quality mindset of the organization. This is achieved within the framework of regulatory compliance and operating within established high BioNTech standards of Quality under GMP.


Your main responsibilities are:


  • Close collaboration and partnership with the Global QA BioNTainer Set-up & Support Team, the Rwanda Quality organization, and the Quality organizations across BioNTech to ensure all regulations and procedures are followed in Rwanda.
  • Support the implementation of GMP standards and procedures, a quality system, documentation control (e.g., change control, deviations, CAPA), training, metrics, audits and inspections, as examples.
  • Help to set up and establish the Rwanda BioNTainer site by ensuring local GMP Quality operations activities and procedures are implemented in compliance to regulations and global policies, with minimal oversight and guidance.
  • Support the Rwanda QA Operations organization in shaping local processes and provide support to local and global stakeholders
  • Responsible for ensuring GMP compliance and performing QA Operations activities for the Rwanda (RWA) BioNTainer site.
  • Establish and implement documentation control (including change control, deviations, investigation, and CAPAs), provide end-to-end document management oversight (e.g., document creation and archiving), and quality system implementation and management, with minimal oversight and guidance.
  • Provide general manufacturing and disposition support (batch records, CoA, EM, TEs, line clearance, CC, deviations and investigations, documentation support, etc.) in partnership with the Technical QA and Product Release functions and with minimal oversight and guidance.
  • Contribute to and support the management of audits and inspections (internal and external).
  • Help to establish and maintain GMP compliance, author procedures and documents (e.g., SOPs), and contribute to regulatory submissions and Annual Product/PQ reviews, with minimal oversight and guidance.
  • Support Quality metrics for the site and continuous improvement initiatives.
  • Continuous learning and development.


What you have to offer:


  • Bachelor’s degree in relevant scientific discipline, and additional qualifications are advantageous.


Professional experience:

  • 4+ years significative experience within the pharmaceutical industry.



  • Fluency in English (written and spoken) is essential.



  • Working knowledge of relevant regulations and guidelines (experience with ICH, US FDA, EMA, etc. are advantageous).
  • Operations experience in one or more pharmaceutical GMP functions.
  • Strong solution driven mindset and desire to learn.
  • Ability to conceptualize, analyze, plan and manage in a fast-paced environment.
  • Ability to be agile, effectively collaborate, and build consensus in a dynamic, cross-functional environment.
  • Excellent interpersonal skills & outstanding communication skills (verbal and written).
  • Ability to navigate through ambiguity and rapid growth and adapt to change.


Benefits for you:

We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.


How to apply: 

Apply now and simply send 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 by using our online form.

Please note: 

  • Only applications sent via our online form shall be considered.
  • Only Candidates with the right qualifications and relevant experience shall be shortlisted and
  • Incomplete applications shall be rejected.
  • Please note that BioNTech will run a background check during the hiring process

We are looking forward receiving your application.

*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!


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