Senior Manager CSSV AI Compliance Lead

Role Summary

Senior Manager CSSV AI Compliance Lead. This role provides strategic leadership and operational quality oversight for development, deployment and enablement of GxP AI capabilities across QSEO and PGS Operations. The AI Compliance Lead enables the deployment of AI initiatives while mitigating risk, and partners with QSEO GPOs and BSOs, Digital, Legal and other stakeholders to ensure AI capabilities built in Pfizer or by third parties adhere to external regulatory requirements and Pfizer policy.

The role helps develop and maintain the AILC framework for PGS, including the inventory of use cases and risk management strategy and tools for AI assessment.

Location:

Hybrid.

• Fulfil the Quality Authority responsibilities for Digital-delivered AI in partnership with other Quality SMEs and GPOs (as defined in AILC/SDLC processes).
• Support and consult with the GPO/BSO in: AI validation and enablement activities;
  Confirming the system meets the specified business requirements;
  Ensuring appropriate business dataset selection for model training;
  Reporting value delivery/ongoing performance of the solution in support of the L2 process.
• Collaborate with the CSQ/BUQA function to ensure adequate system validation and ongoing compliance for target/interfaced GMP/GDP applications.
• Partner and consult with Digital (on-prem and SaaS) in:
  Oversight and approval of validation deliverables, risk assessments and integrations;
  Acceptance and endorsement of the model/system for GxP use;
  Supporting sites to enable timely deployment and adoption;
  Monitoring of AI models;
  Retirement and decommissioning of AI;
  Improvement of Digital and/or system performance/support processes.
• Serve as QSEO point of contact for AI capabilities/ideas for all stakeholder groups.
• Develop QSEO inspection readiness program.
• Support internal audits, BOH inspections and vendor audits.
• Coordinate with other BSOs and GPOs to ensure system and process interdependencies and interfaces are understood.
• Lead the QSEO AI council.
• Serve as SME in QSEO Digital council and Digital sponsor discussions.
• Monitor adherence to standards and risk mitigations across the AI capabilities that are produced.
• Monitor emerging regulations related to AI and ensure continued compliance of the AILC framework.
• Establish outcome-based KPIs, monitor performance and state of control across the QSEO/PGS organization.
• Define applicable training requirements and provide content to ensure compliance, including educating the QSEO organization of standards necessary in the development of AI capabilities, and the need to understand Pfizer’s AI Legal/Compliance guidance.
• Oversee strategy for supplier assessment related to Pfizer’s AI policy and standards.
• Develop standardized monitoring plans for key AI initiatives.
• Role may include business travel to other Pfizer sites, contractors, and suppliers.

• Required: Bachelor's degree with at least 6 years of experience; OR a Master's degree with at least 5 years; OR a PhD with 1+ years of relevant experience.
• Required: Experience in Artificial Intelligence qualification and usage in regulated environments.
• Required: Experience Software Quality Assurance, including risk-based approaches (e.g., CSA, GAMP5, QRM).
• Required: Experience of enterprise system validation/compliance/deployment and good knowledge of Pfizer Digital life cycle methodologies (S/ADLC).
• Required: Demonstrated experience with computer system validation lifecycle processes.
• Required: Intimate knowledge of Computer System Quality and AI regulations/industry guidance.
• Required: Good understanding of Quality Management System regulations.
• Required: Experience of interacting with auditors and inspectors.
• Required: Excellent communication skills with the ability to build relationships, influence outcomes, and to deliver effective viewpoints or presentations to a variety of audiences.
• Required: Command of the English language.
• Required: Be self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.
• Required: Ability to work within tight time frames and respond to changing requirements.
• Required: Ability to interact…