Director of Computer System Assurance & Quality Strategy

Pfizer; United States; In loco; USD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

Pfizer is seeking a Director, Computer System Quality Lead to provide strategic leadership for Computer System Assurance and quality oversight of GMP/GDP computer systems across Pfizer Global Sites and Digital organizations. You will establish risk-based assurance practices and ensure systems remain compliant and inspection-ready throughout their life cycle.

The role collaborates with Quality units to promote alignment, advances AI/automation-enabled assurance, and leads complex cross-functional

Competenze

• 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.
• Strong written and verbal communication skills.

Mansioni

• 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.

Conoscenze

Risk-based assurance

Quality process leadership

Regulatory inspections

Cross-functional leadership

Independent judgment

Formazione

Bachelor's degree in science/engineering/tech/data/quality

Master's degree

Doctoral degree

Descrizione del lavoro

Pfizer is seeking a Director, Computer System Quality Lead to provide strategic leadership for Computer System Assurance and quality oversight of GMP/GDP computer systems across Pfizer Global Sites and Digital organizations. You will establish risk-based assurance practices and ensure systems remain compliant and inspection-ready throughout their life cycle.

The role collaborates with Quality units to promote alignment, advances AI/automation-enabled assurance, and leads complex cross-functional