P

Pfizer

Makes cancer drugs, vaccines and other medicines

Director – QSEO AI Transformation Lead

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeCollegeville, PA, USA

About the Job

Requirements

  • A bachelor's degree in a scientific, engineering, technology, data, quality, or related discipline with at least eight years of relevant experience; alternatively, 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 artificial intelligence and machine-learning concepts, including model life cycle, data quality, performance monitoring, drift, explainability, and human oversight.
  • Ability to evaluate multiple complex and concurrent inputs, exercise sound judgment, and develop clear, actionable recommendations.
  • Ability to manage competing priorities and operate effectively in a complex, matrixed, and globally distributed environment.

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.
  • Lead a team, influence organizational alignment, and advise senior leaders on AI governance, risk, compliance, and deployment considerations.
  • Participate periodically in meetings outside standard working hours to support global stakeholders; undertake occasional business travel based on portfolio and program needs.

Desired Qualifications

  • Advanced degree in a scientific, engineering, data, technology, regulatory, or quality discipline.
  • Experience developing or implementing governance for AI or machine-learning solutions in a GxP environment.
  • Familiarity with applicable AI, quality, and risk-management regulations, standards, and guidance.
  • Experience leading senior governance or multidisciplinary decision-making forums.
  • Experience establishing portfolio-level monitoring, inspection-readiness, or risk-reporting approaches.
  • Quality, auditing, risk-management, Digital, data, or AI-related certification.
  • Experience applying IMEx, Lean, Six Sigma, or comparable process-improvement methods.
  • Experience with portfolio management, governance tools, value reporting, or AI inventory management.
  • Ability to influence and collaborate with peers, develop and coach others, and oversee and guide colleagues' work to achieve meaningful outcomes and business impact.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

Recently Posted Jobs

Explore more opportunities at Pfizer

See more jobs