Technical QA Manager – Manufacturing
BioNTech SE · Kigali
Description du poste
About the role
The Technical QA Manager will lead GMP compliance and technical quality activities for BioNTech’s Rwanda BioNTainer site. You will develop and maintain QA processes, support technology transfer, and foster a quality‑first culture across manufacturing, testing and supply‑chain functions.
Key responsibilities
- Ensure GMP compliance for manufacturing and quality control operations.
- Support technology transfer and establish technical manufacturing, QC, material management, vendor and supply‑chain systems.
- Lead pre‑qualification, qualification and validation activities for processes, equipment, materials and suppliers.
- Provide technical QA input for deviations, investigations and audit inspections.
- Author and maintain SOPs, technical procedures and contribute to regulatory submissions and annual product reviews.
- Develop and monitor quality metrics and drive continuous‑improvement initiatives.
Required profile
- Bachelor’s degree in a scientific discipline; MSc or MBA advantageous.
- 6‑8+ years of experience in the pharmaceutical industry.
- Working knowledge of ICH, US FDA and EMA regulations.
- Proven experience in one or more GMP functions.
- Strong analytical, problem‑solving and communication skills.
- Fluent in written and spoken English.
Required skills
- GMP compliance
- ICH, US FDA and EMA regulatory knowledge
- Process validation and qualification
- Deviation investigation and root‑cause analysis
- Audit support and inspection readiness
- SOP authoring and document control
- Regulatory submission preparation
- Quality metrics analysis and continuous improvement
What we offer
- Competitive benefits package focused on employee wellbeing.
- Opportunity to work on innovative modular mRNA manufacturing (BioNTainers).
- Dynamic, fast‑growing environment with regional impact in Africa.
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BioNTech SE
Kigali
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