Senior Manager CSSV AI Compliance Lead

This role provides strategic leadership & operational Quality oversight for development, deployment and enablement of GxP AI capabilities across QSEO and PGS Operations. The AI Compliance Lead is responsible for enabling the deployment of AI initiatives while ensuring all forms of risk are mitigated. This role partners closely with QSEO GPOs and BSOs, as well as with Digital, Legal and other relevant stakeholders to ensure AI capabilities built in Pfizer or through 3rd parties adhere to applicable external regulatory requirements as well as Pfizer specific policy and controls. The AI Compliance Lead plays a key role in developing and maintaining the AILC framework for PGS, including the inventory of use cases and risk management strategy and tool(s) for AI assessment. The AI Compliance Lead is responsible for ensuring GxP AI and ML use cases are designed, developed, qualified, enabled and monitored appropriately throughout the life cycle, including Quality direction and approval of life cycle documentation. The role is jointly accountable with the CSSV lead to lead the QSEO AI council and represent PGS Quality at various AI operational and compliance cross-functional committees, reporting on AI enablement, risks and value delivery. Additionally, the position supports Computer System Validation & Quality oversight for GMP /GDP Digital systems as necessary, ensuring compliance with Pfizer CSA/SDLC requirements, 21 CFR Part 11, Eudralex Vol 4 Annex 11 & associated global regulations.