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Senior Manager, GDE SOP Excellence

BioNTech SE
August 26, 2026
Full-time
Remote friendly (Cambridge, MA)
Worldwide
Operations
Role: Senior Manager, GDE SOP Excellence, responsible for developing and maintaining SOPs and procedural documentation to ensure regulatory compliance and operational quality within BioNTech's Global Development Organization. Responsibilities include leading SOP governance, process improvement, cross-functional collaboration, and monitoring SOP effectiveness to foster a culture of quality and continuous improvement. Requirements include a Bachelor's degree in Life Sciences, Healthcare, or related fields, with 5+ years of experience in SOP governance, quality systems, or clinical operations within biopharma. Strong knowledge of GCP, quality principles, and technical writing is essential, with proficiency in tools like SharePoint and Visio. High-value specifics involve supporting clinical development processes, ensuring compliance across GDO functions, and promoting operational excellence in a dynamic biotech environment. The role may involve collaboration across multiple US sites (Cambridge, Gaithersburg, New Jersey). The position is based in US locations, with the potential for hybrid work settings.