Senior Director Global Quality Inspection Preparedness and Compliance Excellence
BioNTech · Mainz
Mainz, Germany | full time | Job ID: 11850
About the Job:
In this global leadership role, you will drive enterprise-wide inspection preparedness and strengthen BioNTech auditor capabilities required for internal as well as external audits. You will advance GxP compliance maturity and help ensure sustained inspection readiness.
Your Contribution:
- Lead the global GMP compliance program, advising cross-functional teams on regulatory expectations and emerging trends.
- Define and drive the inspection readiness framework, standards and roadmap for internal sites and CDMOs.
- Lead cross-functional readiness programs and mock inspections; assess gaps, define remediation plans and track implementation to maintain a consistent state of control ahead of authority inspections.
- Establish and oversee the global auditor excellence framework, including auditor selection, qualification and performance oversight. Ensure consistent audit practices, tools, standards and performance measures.
- Advance auditor excellence through strategic development initiatives, project assignments, shadowing and training programs. Ensure compliance training requirements are met and build world-class audit and inspection expertise.
- Establish and oversee the CDMO inspection readiness framework, including audit planning, findings management and escalation. Implement risk-based scoring and preventive measures to proactively reduce quality and supply chain risks.
A Good Match:
- You hold an advanced degree in life sciences or pharmacy.
- You bring extensive GxP experience and a strong track record of supporting and leading health authority inspections.
- You have in-depth expertise in global quality systems (10+ years) and you can translate regulatory expectations into practical, effective approaches across a complex organization.
- You have a proven track record in CDMO oversight, including the ability to strengthen inspection readiness and proactively address quality and supply chain risks.
- You are an excellent stakeholder manager who builds trusted relationships and works effectively across functions, sites and external partners.
- You communicate confidently in English and can engage clearly with stakeholders at all levels.
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 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 11850 (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.
Note for applications within Europe: Please note that if you wish to claim travel expenses incurred in connection with an in-person interview, we are obliged to carry out a sanctions list check*. This is carried out by our partner, HireRight. Travel expenses will only be reimbursed if this sanctions list check does not yield any matches. Reimbursement can be made provided that the check is successfully completed.
* Your first name, surname and date of birth will be processed for the sanctions list check. The legal basis for carrying out the sanctions list check for positions at BioNTech in Europe is BioNTech’s legitimate interest. Please note that BioNTech will not carry out the sanctions list check if no travel expenses are to be reimbursed. If you do not give BioNTech your consent to the sanctions list check, your travel expenses cannot be reimbursed. This will not affect your application.