Berlin Director QA Protein Modality BE 10179

Job description

Director QA Protein Modality Mainz, Germany | full time | Job ID: 11718 About the role: The Director of Product Quality is accountable for end-to-end quality oversight of small molecule and antibody program(s) throughout clinical development, commercialization, filing, approval, launch and post-approval lifecycle management activities. This oversight includes setting and maintaining overall Quality strategies in support of commercialization efforts including: establishing relevant product quality standards for current or novel technologies, ensuring internal and cross-functional alignment with industry and regulatory expectations, identifying product quality risks and mitigations throughout development of the assigned program(s). This role is also responsible for setting up critical systems and standards related to Product Quality across the Global BioNTech network. The candidate will have an excellent understanding of worldwide quality regulations, especially related to drug development and commercialization. Your Contribution: Provide clearly defined Quality expectations and a Quality strategy for the assigned program(s) within the BioNTech product portfolio