Director, QSEO AI Transformation Lead

Pfizer

. Provide strategic leadership for QSEO AI transformation, governance and quality oversight across the PGS AI portfolio .

Posted 10/22/2026full-timeCollegeville • Pennsylvania • United StatesSenior💰 $176,600 - $294,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GxP Quality Systems, Risk Management, and AI Governance, with a strong focus on regulatory compliance and quality oversight throughout the AI life cycle. Proven ability to lead cross-functional initiatives and influence senior leaders while maintaining alignment across Quality, Digital, and Operations.

Highest-signal resume keywords

GxP Quality SystemsAI GovernanceRisk ManagementRegulatory ComplianceDigital Quality

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Applicant Tracking System Keywords

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Hard Skills

Quality OversightRisk AssessmentAI Life Cycle ManagementDigital GovernanceRegulatory Inspection SupportCross-Functional LeadershipQuality Metrics DevelopmentComputerized Systems ExpertiseAI and Machine Learning ConceptsAudit and Inspection Readiness

Soft Skills

Influencing Senior LeadersStrong Written CommunicationVerbal Communication SkillsIndependent JudgmentProblem-Solving

Tools & Technologies

AIRIFAIQAS

Industry Keywords

Pharmaceutical QualityManufacturing ComplianceRegulated EnvironmentDigital SolutionsAI Solutions

About the role

Key responsibilities & impact

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
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 decisions, escalation and closure of 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 implications into 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 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 portfolio-level monitoring of 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
Develop portfolio metrics and insights for senior leaders on AI adoption, quality, compliance, risk and value
Lead QSEO AI-related IMEx reporting, resource visibility, risk assessment and escalation
Lead a team and influence alignment across organizational and functional boundaries
Participate periodically in meetings outside standard working hours and undertake occasional business travel as needed

Requirements

What you’ll need

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
Candidates must be authorized to be employed in the U.S. by any employer
Permanent work authorization in the United States is required
U.S. work visa sponsorship is not available now or in the future

Benefits

Comp & perks

Pfizer Global Performance Plan with a bonus target of 20.0% of base salary
Share-based long-term incentive program eligibility
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Medical, prescription drug, dental and vision coverage
Potential relocation assistance based on business needs and/or eligibility