Senior Director Global Quality Supply
BioNTech · Mainz
Mainz, Germany | full time | Job ID: 11366
About the role:
We are seeking an experienced leader to provide global oversight of Quality Assurance (QA), compliance, and integrity for clinical and commercial supply. This role focuses on end-to-end commercial packaging, labeling, serialization, storage, and distribution—ensuring sustained Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance across a complex global partner network. You will safeguard product quality and patient safety while driving operational excellence and inspection readiness.
Your Contribution:
- Global Supply Quality Leadership: Drive the global quality strategy for packaging, labeling, serialization, storage, and distribution to ensure inspection readiness and regulatory compliance across regions. Provide senior QA oversight for packaging processes, artwork governance, and change management while leading and developing the Global Quality Supply team for consistent execution worldwide.
- Product Traceability: Establish QA governance for serialization and product traceability to meet regulatory requirements, ensuring data integrity and robust processes across CMOs, depots, logistics partners, and markets.
- Lifecycle Management: Provide QA oversight for late-stage development transitioning into commercial supply, managing change controls for packaging, labeling, serialization, and distribution. Ensure compliance and risk controls during scale-up, market expansion, and supply chain adjustments.
- Distribution, Storage & Global Trade Compliance: Oversee QA governance for storage, transportation, and distribution, including cold chain management and shipping validation. Ensure compliance with GDP, import/export regulations, and distribution licensing requirements within a harmonized global framework.
- Risk Management, Deviations & Recalls: Manage incidents, deviations, investigations, and CAPAs related to packaging, serialization, storage, and distribution. Support global recalls and critical supply incidents while driving proactive risk management and continuous improvement aligned with ICH Q9 and ICH Q10.
- Partner & Stakeholder Leadership: Collaborate with Supply Chain Management, Commercial Operations, Regulatory Affairs, and external partners (e.g., CMOs, packaging sites, depots, logistics providers) to define quality responsibilities and ensure accountability across the supply network through technical and quality agreements.
A good Match:
- Hold a degree in a relevant field (e.g., Pharmacy, Chemistry, Biotechnology, or related discipline).
- Bring 10+ years of pharmaceutical QA experience with a strong focus on commercial pharmaceutical supply (e.g., DSCSA, FMD).
- Demonstrate senior-level experience in commercial packaging, labeling, serialization, storage, and distribution quality, including partner oversight.
- Apply deep knowledge of global regulatory requirements (e.g., FDA, EMA, WHO) and industry standards (GDP, GMP), with experience implementing and maintaining compliant quality frameworks.
- Harmonize global processes while integrating country-specific requirements to enable efficient, unified strategies.
- Identify, assess, and mitigate risks in supply chain and distribution processes, driving continuous improvement initiatives.
- Lead global teams, drive cross-functional alignment, and make sound, risk-based decisions in complex environments.
- Communicate effectively with internal and external stakeholders to align quality assurance efforts with broader business objectives.
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 11366 (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.