Manager, Global Quality Intelligence & Product Quality Complaints (remote)

Role: Manager in Global Quality Intelligence & Product Quality Complaints responsible for establishing and maintaining a comprehensive GMP compliance oversight framework for BioNTech's global pharmaceutical activities. Primary objectives include overseeing end-to-end complaint management for clinical trial materials and commercial products, ensuring regulatory compliance, and driving continuous quality improvement across the product lifecycle. Responsibilities involve managing complaint investigations, CAPAs, and third-party activities; maintaining compliance with global regulations such as GMP, ICH Q10, and CFR Part 211; coordinating with internal functions and external partners; supporting inspections, audits, and quality metrics reporting; and enhancing the digitalization of the Quality Management System. Qualifications: Bachelor’s in Pharmacy, Chemistry, Biology, or related field; 5+ years in pharmaceutical Quality MAH/Sponsor roles; deep knowledge of GMP, regulatory standards, and complaint management; strong communication and collaboration skills; proven ability to manage compliance and quality risks. High-Value: Focus on pharmaceutical quality oversight, complaint management, GMP compliance, regulatory inspections, and cross-functional collaboration within a global biopharma context. Work setup: Full-time roles based in New Jersey, Cambridge, or Gaithersburg, with potential for regional or international collaboration.