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

BioNTech SE is a leading biopharmaceutical company focused on transforming the treatment of diseases. The Manager in Global Quality Intelligence & Product Quality Complaints will establish and improve a comprehensive Global Quality Assurance oversight framework to ensure GMP compliance and manage the end-to-end complaint handling process for clinical trial materials and commercial products.

Responsibilities:

• Ensure regional and global compliance in the capacity of an MAH/Sponsor representative by addressing evolving global regulatory expectations
• Contribute to the development and maintenance of procedures, training, and quality oversight processes supporting product lifecycle, regulatory surveillance, recalls, and related MAH/Sponsor responsibilities
• Build and maintain processes (e.g. Product Specification Files (PSFs)) ensuring compliance with product‑relevant regulatory documentation (BLAs, MAAs, IMPDs, etc)
• Manage the end-to-end lifecycle of Product Quality Complaints (PQC) for clinical trial materials and commercial pharmaceutical products, ensuring effective intake, triage, assessment, investigation, classification, disposition, and closure
• Ensure compliance with global regulatory requirements, internal procedures, and reporting obligations related to complaint handling
• Lead complaint investigations and CAPAs, oversee third-party activities, and drive the timely escalation of quality and compliance risks
• Serve as the primary point of contact for PQC-related activities, fostering effective collaboration across Quality, Pharmacovigilance, Medical Information, Release Hub, Supply Chain, and external partners
• Support and represent the organization during inspections and audits related to MAH/Sponsor oversight and complaint handling, providing expertise, coordinating responses, and ensuring timely resolution of observations
• Provide regular updates to leadership on quality metrics, compliance risks, escalations, and key achievements to support informed decision-making
• Contribute to the standardization, globalization, digitalization, and continuous improvement of the BioNTech Quality Management System and associated processes
• Act as a mentor and role model, promoting a culture of quality, compliance, accountability, and continuous improvement
• Perform additional duties and responsibilities as required to support departmental and business objectives

Requirements:

• Degree in Pharmacy, Chemistry, Biology, or a related scientific field
• Extensive experience (5+ years) in Quality MAH/Sponsor responsibilities
• Proven track record of Product Quality Complaint Management, GMP compliance, and regulatory processes within the pharmaceutical industry
• Strong knowledge of GMP guidelines, ICH Q10, CFR Part 211 and regional/national regulatory requirements
• Exceptional communication and networking skills to foster collaboration across teams and stakeholders
• Excellent written and verbal communication skills in English
• Proven track record of critical thinking and agility. This includes the ability to manage priorities, track progress of key projects, and provide updates to leadership, as required