Senior Manager CSSV AI Compliance Lead

Pfizer • Philadelphia, MS

2d • Hybrid

About The Position

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.

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).

Nice To Haves

• 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.

Responsibilities

• 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
• Role may include business travel to other Pfizer sites, contractors, and suppliers.

Benefits

• In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program.
• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees