Director, Computer System Quality Team Lead

ROLE SUMMARY

The Director, Computer System Quality Lead provides strategic and subject-matter leadership for Computer System Assurance and the quality oversight of GMP/GDP computer systems across PGS sites and Digital organizations. The role establishes and advances consistent, risk-based assurance practices for enterprise Digital, artificial intelligence and federated solutions, ensuring systems remain appropriately controlled, monitored, compliant and inspection-ready throughout their life cycle.

Serving as the Quality authority for the Digital process framework, the Director applies deep functional expertise and independent judgment to complex system risk assessments, classifications, assurance strategies and compliance matters. The role partners with Pfizer business Quality units to promote alignment, resolve differing interpretations and support consistent application of the framework across organizational boundaries.

Working across Quality, Digital, sites and business functions, the Director leads complex cross-functional initiatives and advises senior leaders on assurance, compliance risk, regulatory expectations and inspection readiness. The role advances innovative and technology-enabled approaches, including artificial intelligence, automation and continuous monitoring, to simplify Computer System Assurance while maintaining appropriate patient, product-quality and data-integrity protections.

ROLE RESPONSIBILITIES

• Define and advance risk-based Computer System Assurance strategies and practices across PGS sites and Digital organizations.
• Serve as the Quality authority for the Digital process framework, promoting consistent interpretation and application across Pfizer business Quality units.
• Provide authoritative quality decisions and recommendations for complex enterprise-system risk assessments, classifications and assurance approaches.
• Establish quality oversight for the validation and ongoing management of GMP/GDP enterprise Digital, artificial intelligence and federated solutions.
• Provide strategic leadership for the Level 2 Computer System Assurance process, including governance, maintenance, adoption, continuous improvement, process-change management, metrics and inspection support.
• Lead portfolio-level audit and inspection readiness, identify systemic risks and recommend corrective or preventive actions.
• Provide subject-matter leadership for significant computerized-system investigations, compliance risks and escalations.
• Represent computerized-system quality matters during regulatory inspections, internal audits and senior governance forums.
• Monitor evolving regulatory expectations and industry practices and translate their implications into practical quality strategies, standards and controls.
• Identify and advance opportunities to simplify Computer System Assurance through artificial intelligence, automation and other Digital capabilities.
• Define risk-based approaches for continuous system-health monitoring and periodic review.
• Provide strategic oversight for the enhancement, adoption and value realization of Computer System Assurance and EDES.
• Monitor Computer System Assurance network health and recommend improvements to governance, capability and execution.
• Lead related IMEx reporting, resource visibility, risk assessment and escalation.
• Partner with Business System Owners, Global Process Owners, Digital, artificial intelligence teams, portfolio management, Governance, Risk and Compliance, and other stakeholders to align assurance practices with business and portfolio priorities.
• Provide strategic support to and deputize for the Computer System Assurance Global Process Owner, as appropriate.

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 computerized-system quality, Computer System Assurance or computerized-system validation within a GMP/GDP or similarly regulated environment.
• Demonstrated expertise in risk-based assurance, validation, quality-risk management and the ongoing management of regulated computer systems.
• Experience providing subject-matter leadership for a significant quality process, including process maintenance, adoption, continuous improvement and inspection support.
• Demonstrated experience leading complex, cross-functional initiatives in a global, highly matrixed organization.
• Experience representing Quality during regulatory inspections, internal audits or inspection-readiness activities.
• Demonstrated ability to exercise independent judgment and develop defensible recommendations for complex and ambiguous quality or compliance matters.
• Proven ability to influence senior leaders and align Quality, Digital, site and business stakeholders without direct authority.

…