Senior Director Global Quality Supply

Responsibilities

• Provide global oversight of Quality Assurance, compliance, and integrity for clinical and commercial supply.
• Drive global quality strategy for packaging, labeling, serialization, storage, and distribution.
• Establish QA governance for product traceability to meet regulatory requirements across CMOs and logistics partners.
• Oversee QA governance for storage, transportation, and distribution, including cold chain management and shipping validation.
• Manage incidents, deviations, investigations, and CAPAs related to the supply chain.
• Collaborate with Supply Chain, Regulatory Affairs, and external partners to define quality responsibilities and technical agreements.

Requirements

• Degree in Pharmacy, Chemistry, Biotechnology, or a related scientific discipline.
• 10+ years of pharmaceutical QA experience with a strong focus on commercial supply (e.g., DSCSA, FMD).
• Senior-level experience in commercial packaging, labeling, serialization, and distribution quality.
• Deep knowledge of global regulatory requirements including FDA, EMA, and WHO.
• Extensive experience with GDP and GMP compliance and implementing quality frameworks.
• Proven ability to lead global teams and manage complex stakeholder relationships.

Benefits

• Flexible working hours and vacation accounts.
• Professional growth through digital learning, leadership development, and LinkedIn Learning.
• Health and lifestyle support including company bikes and job tickets.
• Financial security through employer-funded pensions and childcare support.

About the Company

BioNTech is a biotechnology company dedicated to revolutionizing medicine by translating cutting-edge science into survival. We are a community of innovators and scientists working to address high medical needs, such as cancer and infectious diseases, to improve global health.