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Location

Wiesbaden | Germany

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Job description

Become a member of the BioNTech Family!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards - writing medical history.

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

(Associate) Director (m/w/d) Product Quality - mRNA Oncology

The (Associate) Director (m/w/d) of Product Quality is accountable for end-to-end quality oversight of mRNA Oncology 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. The ideal candidate must be able to influence, communicate, and partner effectively with global and site development functions (R&D, process development, analytical development, Manufacturing Science and Technology, Analytical Science and Technology, Product Supply, Regulatory, Site Quality and QC) to enable a robust product development (QbD) approach.

Aufgaben:

• 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
• Ensure significant Quality risks are escalated and properly mitigated in a timely manner
• 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

Qualifikationsprofil:

• Minimum Bachelor’s degree (or University equivalent), Life Sciences or similar technical/scientific degree
• Minimum of eight (8) years industry experience or ten (10) years' experience with an advanced degree
• 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

Benefits:

• Flexible Working Time
• Mobile Office
• Work from EU Countries (up to 20 days per year)
• Company Pension Scheme
• Childcare
• Jobticket
• Company Bike
• Leave Account
• Fitness Courses

... and much more.

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Job tags

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Salary