Manager Technical QA (Manufacturing)

About the role:

As Manager Technical QA you will be Responsible for ensuring GMP compliance and performing Technical QA activities for the Rwanda (RWA) BioNTainer Site. Responsible for establishing, maintaining, and developing Technical QA 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 contribution:
• Responsible for ensuring GMP compliance and performing Technical QA for mfg and QA for QC activities for the Rwanda (RWA) BioNTainer site.
• Support technology transfer (manufacturing and testing), and the establishment and management of technical manufacturing, QC, material management, vendor and supplier, and supply chain systems and operations at the site.
• Support all pre-qualification, qualification, validation activities (process, testing, material, vendor/supplier, etc.).
• Support and provide technical QA input and guidance for deviations and investigations; provide support during audits and inspections (internal and external).
• Help to establish and maintain GMP compliance, author technical procedures and documents (e.g., SOPs), and contribute to regulatory submissions and Annual Product/PQ reviews.
• Support the development and management of Quality metrics and continuous improvement initiatives for the site.
• Continuous learning and development.

A good match:
• Bachelor’s degree in relevant scientific discipline 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).

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