Manager Technical QA

About the job

Kigali, Rwanda | full time | Job ID: 10349As 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 main responsibilities are:

• 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, and 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.

What you have to offer:

• Bachelor’s degree in a relevant scientific discipline, additional qualifications (MSc, MBA) are advantageous
• 6-8+ years of significant experience within the pharmaceutical industry.
• Working knowledge of relevant regulations and guidelines (experience with ICH, US FDA, EMA, etc. are advantageous).
• Technical 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) is essential

Your Benefits:

BioNTech is committed to the well-being 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.

Skills Required:

• Pharmaceutical