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 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 and 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 and associated global regulations. Duties may be adjusted based on the group’s requirements and needs.

ROLE 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 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 (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 continued 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 and standards.
• Develop standardized monitoring plans for key AI initiatives.

BASIC QUALIFICATIONS

• Applicant must have a bachelor's degree OR a master's degree with strong relevant experience; OR a PhD with limited 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.

PREFERRED QUALIFICATIONS

• 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.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: Hybrid (some office presence is required)

Purpose Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.

Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!