Manager QA Ops & Systems

Kigali, Rwanda   |   full time   |   Job ID: 9847 

As Manager QA Ops and Systems, you are responsible for ensuring GMP compliance and performing Quality Assurance (QA) Operations activities for the Rwanda (RWA) BioNTainer site. Responsible for establishing, maintaining, and developing QA Operations processes for the Site. This role will also be responsible for helping to develop and ensure the Quality mindset of the organization and preserve 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.  

Your responsibilities are:

• 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.
• 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.  
• Contribute to and support the management of audits and inspections (internal and external), and the development and implementation an inspection readiness process.
• Help to establish and maintain GMP compliance, author procedures and documents (e.g., SOPs), and contribute to regulatory submissions and Annual Product/PQ reviews.
• Support and help manage Quality metrics and continuous improvement initiatives for the site.
  Continuous learning and development.

What you have to offer:

• Bachelor’s degree in relevant scientific discipline, and additional qualifications (MSc, MBA) are advantageous.
• 6-8+ years significative experience within the pharmaceutical industry.
• Working knowledge of relevant regulations and guidelines (experience with ICH, US FDA, EMA, etc. are advantageous
• Experience with participation in national or international regulatory agencies is 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.
• Fluency in English (Written and Spoken)

Your Benefits:

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.

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.