Director, QSEO AI Transformation Lead

ROLE SUMMARY

The Director, QSEO AI Transformation Lead provides strategic and subject-matter leadership for artificial intelligence governance, quality oversight and responsible adoption across Pfizer Global Supply (PGS) and Quality, Safety, Environment & Operations (QSEO). The role enables the Native-AI vision by establishing the governance, quality frameworks and AI life-cycle practices needed to accelerate AI adoption while maintaining appropriate GxP controls, regulatory compliance and inspection readiness.

Operating at the intersection of Quality, Digital and Operations, the Director applies deep functional expertise and independent judgment to complex and evolving AI opportunities, risks and regulatory expectations. The role translates these considerations into practical, risk-based approaches that enable innovation and process simplification while maintaining appropriate oversight throughout the AI life cycle.

Working across organizational and functional boundaries, the Director leads complex cross-functional initiatives, leads a team and influences alignment and advises senior leaders on AI governance, risk, compliance and deployment considerations. The role anticipates emerging issues, develops recommendations and drives resolution of complex challenges through matrix leadership and subject-matter expertise.

ROLE RESPONSIBILITIES

• Provide strategic leadership for QSEO AI transformation, governance and quality oversight across the PGS AI portfolio.
• Translate the Native-AI vision into governance strategies, quality approaches and implementation plans that accelerate responsible AI adoption.
• Advise senior leaders on AI opportunities, regulatory expectations, GxP risks, investment priorities and deployment considerations.
• Establish and maintain risk-based quality oversight for Digital and federated AI solutions throughout the AI life cycle.
• Lead the AI Quality Review Board and GxP AI Steering Committee, driving effective decisions, escalation and closure of agreed actions.
• Establish portfolio-level approaches for AI audit and inspection readiness, identifying systemic risks and recommending corrective or preventive actions.
• Monitor emerging AI regulations, standards and industry practices and translate their implications into practical internal requirements and recommendations.
• Represent QSEO in enterprise AI governance forums and lead resolution of actions arising from the PGS AI Council.
• Provide strategic leadership for maintenance, adoption and continuous improvement of the AI life-cycle process.
• Simplify AI governance and delivery processes while maintaining appropriate quality, compliance and risk controls.
• Establish expectations for accurate AI inventory management and influence an integrated enterprise approach to AI life-cycle visibility.
• Define and advance a portfolio-level approach for monitoring the health, performance and control status of GxP-relevant AI solutions.
• Provide strategic direction for PGS AI governance and quality tools, including AIRIF and AIQAS, and their alignment with the PGS platform strategy.
• Establish and guide the QSEO AI community of practice, partnering with PGS GxP AI ambassadors and relevant PGS, Digital and Research & Development organizations.
• Develop portfolio metrics and insights that provide senior leaders with visibility into AI adoption, quality, compliance, risk and value.
• Lead QSEO AI-related IMEx reporting, resource visibility, risk assessment and escalation.

BASIC QUALIFICATIONS

• Bachelor’s degree in a scientific, engineering, technology, data, quality or related discipline with at least eight years of relevant experience; or a master’s degree with at least seven years of relevant experience; or a doctoral degree with at least five years of relevant experience.
• Significant experience in pharmaceutical quality, manufacturing, regulatory compliance, Digital quality or another regulated environment.
• Demonstrated expertise in GxP quality systems, risk management, computerized systems, Digital governance, AI governance or related disciplines.
• Experience applying quality and risk-management principles across the life cycle of Digital, computerized or AI-enabled solutions.
• Demonstrated experience leading complex, cross-functional initiatives in a global, highly matrixed organization.
• Experience supporting regulatory inspections, internal audits or inspection-readiness activities as a subject-matter expert.
• Demonstrated ability to exercise independent judgment and develop recommendations for highly complex and ambiguous issues.
• Proven ability to influence senior leaders and drive alignment across Quality, Digital, Operations and business stakeholders without direct authority.
• Strong written and verbal communication skills, including the ability to translate technical and regulatory issues into clear business and risk insights.
• Working knowledge of AI and machine-learning concepts, including model life cycle, data quality, performance monitoring, drift, explainability and human oversight.

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