Director, Computer System Quality & Assurance

Pfizer; Pennsylvania; Hybrid; USD 177,000 - 294,000; Full time

Benefits offered by this job

401(k) plan with matching

Pfizer Retirement Savings Contribution

Health benefits

Paid vacation

Paid holidays

Paid caregiver/parental leave

Job summary

Pfizer seeks a Director of Computer System Quality Lead to provide strategic leadership for Computer System Assurance and the quality oversight of GMP/GDP computer systems across Pfizer sites and Digital organizations. You will advance risk-based assurance, promote alignment with Quality units, and drive innovative, compliant, inspection-ready approaches in enterprise Digital, AI, and federated solutions.

As the Quality authority for the Digital process framework, you will apply deep expertise,

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.
• Strong written and verbal communication skills, including the ability to translate technical assurance matters into clear quality, risk and business implications.

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.

Skills

Risk-based assurance

Quality governance

Regulatory inspections

Cross-functional leadership

Independent judgment

Strategic leadership

Communication (written/verbal)

Education

Bachelor’s degree in scientific/engineering/tech/data/quality

Master’s degree in same field

Doctoral degree in related discipline

Job description

Pfizer seeks a Director of Computer System Quality Lead to provide strategic leadership for Computer System Assurance and the quality oversight of GMP/GDP computer systems across Pfizer sites and Digital organizations. You will advance risk-based assurance, promote alignment with Quality units, and drive innovative, compliant, inspection-ready approaches in enterprise Digital, AI, and federated solutions.

As the Quality authority for the Digital process framework, you will apply deep expertise,