About this opportunity
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
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
Your Benefits:
It's our priority to support you:
Your flexibility: flexible hours | vacation account
Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
Your health and lifestyle: Company bike
Your mobility: Job ticket | Deutschlandticket
Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 11718 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
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Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 81 comparable Director Quality roles across 28 biopharma companies.
Salary context
43 of 81 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 81 comparable roles
+ 12 more countries
Seniority mix
81 of 81 peers have a known seniority level
Therapeutic area mix
0 of 81 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
No peers with a known therapeutic area yet.
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.