Manager, Technical QA – Manufacturing

Role Overview

• 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.

Requirements

• Bachelor’s degree in relevant scientific discipline; additional qualifications (MSc, MBA) are advantageous
• 6-8+ years 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.

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 are determined by the specific role, location of employment, and also the selected candidate’s qualifications and experience.