Director QA Protein Modality

Director QA Protein Modality

BioNTech

Mainz, Germany

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;
• Critically evaluate new products and processes with respect to Quality and compliance requirements. Work with development and product supply functions to improve manufacturing processes, new product introduction standards, and overall program strategy and keep current with global regulatory expectations;
• Identify risks and proactively work with project teams and stakeholders to mitigate risks during clinical development, validation, submission, and launch;
• Creating structured approaches to communication and governance to support the product quality network;
• Leading and influencing cross-functional teams to define and effectively implement product lifecycle processes and standards;
• Provide a network for product intelligence and ensuring product information is available and approved;
• Provide quality support for preparation of CMC clinical and commercial regulatory submissions and associated Health authority questions for the program(s) assigned;
• Provide Supplier Quality Oversight for key CDMOs.

A good Match:

• Minimum Bachelor’s degree (or University equivalent), Life Sciences or similar technical/scientific degree;
• Minimum of fifteen (15) years industry experience or 12 years' experience with an advanced degree in Quality Assurance;
• Previous experience in an FDA or EMA (and/or other Health Authority) regulated environment and familiar with Health Authority regulations and guidance;
• Demonstrates expertise of compliance requirements, and an understanding of current global and regional trends in compliance;
• Experience in pragmatic implementation of cGMP and regulatory guidelines;
• Knowledge of compliance requirements for manufacturing and testing mRNA or biologics preferred;
• International and Domestic Travel required up to 20%;
• Refined colloquial and correspondence skills in English; presentation skills adaptable to all levels of internal and external stakeholders.