Summary
Date Posted: Thursday, February 16, 2023 , Base Salary: Not Disclosed

JOB DETAILS:
Qssr-Bnt-Sqa-Senior Director Qa
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 Summary:
You are responsible to establish, maintain and develop Quality Assurance, Product release teams. Within this important position, you are responsible to establish and maintain a Quality mindset of the organization and preserving compliance with national and international regulations. This is achieved within the framework of regulatory compliance and operating within established high BioNTech standards of Quality under GMP.

Tasks:
• Close collaboration with the global BioNTech Quality organization to ensure all GMP relevant regulations and rules are followed in Rwanda
• Build, maintain and develop a team of Quality (QA and releasing function) experts
• Ensure that the globally defined pharmaceutical Quality system is implemented and adhered to
• Represent the BioNTech Rwanda Quality Assurance organization to internal (local and global) and external stakeholders; including support of shaping of local regulations
• Ensure a fit-for-purpose Quality Assurance organization in Rwanda including continuous improvement
• Efficiently manages all site Quality Assurance resource allocation
• Anticipating and balancing the needs of multiple stakeholders including health authorities
• Leading team leads from Quality Assurance and Product Release
• Enable compliant solutions for Quality related questions

Qualifications:
Education:
Bachelor’s degree in a relevant scientific discipline and additional qualifications (MSc, PhD, MBA) are advantageous

Professional experience:
• +10 years significative experience within the pharmaceutical industry

Languages:
• Fluency in English (written and spoken) is essential

Competencies:
• Working knowledge of relevant regulations
• Strong solution-driven mindset
• Ability to work across multiple business functions to build consensus
• Experience leading team/budget
• Experience in hosting inspections 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.">

Job Experience: No Requirements

Work Hours: 8

Level of Education: Bachelor Degree

Job application procedure
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.



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