About the role

Strategic leadership & operational Quality oversight for AI capabilities in GxP settings at Pfizer. Collaborating with stakeholders to ensure compliance and effective risk management across projects.

Responsibilities

Provide strategic leadership & operational Quality oversight for development, deployment and enablement of GxP AI capabilities across QSEO and PGS Operations.
Ensure AI initiatives are enabled while mitigating risks.
Partner closely with QSEO GPOs and BSOs and stakeholders to ensure adherence to regulatory requirements and company policies.
Develop and maintain the AILC framework for PGS, including inventory of use cases and risk management strategy and tool(s) for AI assessment.
Ensure GxP AI and ML use cases are designed, developed, qualified, enabled and monitored throughout the life cycle.
Lead the QSEO AI council and report on AI enablement, risks and value delivery.
Support Computer System Validation & Quality oversight for GMP/GDP Digital systems as required.
Fulfill Quality Authority responsibilities for Digital-delivered AI in partnership with Quality SMEs and GPOs.
Collaborate in AI validation and enablement activities, ensuring systems meet business requirements and appropriate dataset selection for model training.
Serve as QSEO point of contact for AI capabilities and develop inspection readiness program.

Bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of relevant experience
Experience in Artificial Intelligence qualification and usage in regulated environments
Experience Software Quality Assurance, including risk-based approaches (e.g., CSA, GAMP5, QRM)
Experience of enterprise system validation/compliance/deployment and good knowledge of Pfizer Digital life cycle methodologies (S/ADLC)
Demonstrated experience with computer system validation lifecycle processes
Intimate knowledge of Computer System Quality and AI regulations/industry guidance
Good understanding of Quality Management System regulations
Experience of interacting with auditors and inspectors.
Excellent communication skills with the ability to build relationships, influence outcomes, and to deliver effective viewpoints or presentations to a variety of audiences.
Command of the English language
Be self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.
Ability to work within tight timeframes and respond to changing requirements.
Ability to interact comfortably with all levels of management and colleagues.
Ability to work independently and manage multiple projects simultaneously.
Competency in MS Office and other tools (e.g., MS Project).
Basic understanding of data analytics and statistics

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Paid holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage