• Full Time
  • Kigali

Website BIONTECH

Who we are:
As BioNTech, We are a global immunotherapy company. Our 3,000+ 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 toward 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.

Role Purpose:

You are responsible to establish, develop and lead Quality Control teams, set up the QC labs, manage proper transfer and implementation of all required global QC procedures (e.g. equipment qualification, method validation, material, and product testing and release, environmental monitoring, and documentation), and guarantee their routine application in full compliance with applicable pharmaceutical standards, in particular the relevant national and international cGMP regulations.

Tasks:

  • Close collaboration with the Global Head of QC BioNTainers to implement all QC-related processes according to defined global standards
  • Guide and oversee set-up and commissioning of analytical and microbiological QC labs including equipment qualification
  • Support hiring for locally required QC employees and ensure proper training and qualification
  • Ensure successful transfer/validation of time-critical compendial test methods
  • Implement effective and reliable sample management and raw material testing and release processes
  • Interface to global quality control organization to ensure state-of-art testing strategy and ensure continuous improvement
  • Leading local QC Managers, Specialists, and Operators
  • Ensure the implementation of testing processes with regard to cost efficiencies, ecology, quality, and safety to maintain the GMP status
  • Approve starting materials, packaging materials, bulk and finished products (Drug Substance and Drug Product)
  • Ensure that all necessary testing is carried out and the associated records evaluated
  • Approve specifications, sampling instructions, test methods, and other Quality Control procedures
  • Approve and monitor any contract laboratories
  • Ensure the qualification and maintenance of his/her department, premises, and equipment
  • Ensure that the appropriate validations are done
  • Ensure that the required initial and continuing training of his/her department personnel is carried out and adapted according to need
  • Measuring KPIs and supporting quality reviews
  • Ensure that globally assigned activities (full cycle of drug substance and drug product testing) are performed in a timely manner while observing all internal and regulatory requirements
  • Lead investigations for OOSs in collaboration with subject matter experts
  • Ensure that change control procedures are initiated and executed appropriately

Qualifications:

Education

Bachelor’s degree in relevant scientific discipline (e.g., Biology, Chemistry, Pharmacy) additional qualifications (MSc, PhD, MBA)

Professional experience

  • 5+ years of significate experience within the pharmaceutical industry
  • Regulatory and legal requirements experience

Languages

Fluency in English (written and spoken) is essential

Competencies

  • Working knowledge of relevant local and international regulations
  • Strong understanding of pharmaceutical business and quality governance
  • Broad knowledge and practical experience of analytical sciences and technologies
  • Strong quality and analytical mindset
  • Experience leading team/budget
  • Experience in hosting and collaborating with national or international regulatory agencies
  • Excellent interpersonal skills
  • Outstanding communication skills (verbal and written)
  • Ability to conceptualize, analyze, plan and manage in a fast-paced environment.
  • Ability to be agile and effectively collaborate in a dynamic, cross-functional environment.
  • Ability to navigate through ambiguity and rapid growth and adapt to change.
  • Honest, open-minded, transparent, solution-driven, continuous improvement focus.

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.

 

To apply for this job please visit qsourcingservtec.applytojob.com.