Director leading strategies for AI hardware and advanced compute solutions at HP. Collaborating with cross - functional teams to execute competitive market strategies.
About the role
- Strategic leadership & operational Quality oversight for AI capabilities in GxP settings at Pfizer. Collaborating with stakeholders to ensure compliance and effective risk management across projects.
Responsibilities
- Provide strategic leadership & operational Quality oversight for development, deployment and enablement of GxP AI capabilities across QSEO and PGS Operations.
- Ensure AI initiatives are enabled while mitigating risks.
- Partner closely with QSEO GPOs and BSOs and stakeholders to ensure adherence to regulatory requirements and company policies.
- Develop and maintain the AILC framework for PGS, including inventory of use cases and risk management strategy and tool(s) for AI assessment.
- Ensure GxP AI and ML use cases are designed, developed, qualified, enabled and monitored throughout the life cycle.
- Lead the QSEO AI council and report on AI enablement, risks and value delivery.
- Support Computer System Validation & Quality oversight for GMP/GDP Digital systems as required.
- Fulfill Quality Authority responsibilities for Digital-delivered AI in partnership with Quality SMEs and GPOs.
- Collaborate in AI validation and enablement activities, ensuring systems meet business requirements and appropriate dataset selection for model training.
- Serve as QSEO point of contact for AI capabilities and develop inspection readiness program.
Requirements
- 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
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Paid holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
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