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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

The annual base salary for this position ranges from $124,400.00 to $201,400.00. 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

Quality Assurance and Control