Use Your Power for Purpose
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.
Duties may be adjusted based on the group’s requirements and needs.
What You Will Achieve
Duties include but are not limited to the following:
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 the target/interfaced GMP/GDP applications
Partner and consult with Digital (for both on-prem and SaaS solutions) in:
Oversight and approval of validation deliverables, risk assessments and integrations
Acceptance & 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 (Board of Health) 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 continue compliance of AILC framework
Establish outcome based Key Performance Indicators (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 & standards
Develop standardized monitoring plans for key AI initiatives
Role may include business travel to other Pfizer sites, contractors, and suppliers.
Here Is What You Need (Minimum Requirements)
Applicant must have a 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
Bonus Points If You Have (Preferred Requirements)
Involvement in industry discussion forums on QMS/CSV/AI-related topics.
Experience of software development, validation, risk management and delivery.
Experience of Data science/engineering.
Physical/Mental Requirements
Role may include business travel to other Pfizer sites, contractors, and suppliers.
Position manages no colleagues.
Position may be required to coach/supervise junior colleagues and temporary resources.
Colleague receives minimal supervision, guidance and direction, work assignments from manager/TL.
Work Location Assignment: Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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