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Manager Quality Intelligence & Strategy

BioNTech SE · Cambridge, Massachusetts, US

Cambridge, US | full time | Job ID: 11194 About the role: The Manager Quality Intelligence & Strategy is responsible for establishing, implementing, and cont...

Job description

Cambridge, US | full time | Job ID: 11194 About the role: The Manager Quality Intelligence & Strategy is responsible for establishing, implementing, and continuously improving a comprehensive Global Quality Assurance (QA) oversight framework to ensure robust GMP/GDP compliance for Marketing Authorization Holder (MAH) and Sponsor‑related activities across the global pharmaceutical footprint. This role drives strategic QA execution across multiple regions and ensures alignment with regulatory expectations, operational excellence, and sustainable quality systems. This role supports improvement projects such as notification management from manufacturing network, Regulatory guidance surveillance and continuous improvement of GMP escalations process. Your Contribution: - Serve as Manager, Quality Intelligence & Strategy with a focus on GMP and compliance processes to fulfill MAH/Sponsor responsibilities. This includes designing, maintaining, and optimizing the process landscape to support compliance and operational excellence. - Support discussions and decision making with strategic partners on complex GMP and compliance topics. Responsibilities include coordinating and preparing compreh...