Director, Computer System Quality & Assurance

Pfizer; Collegeville (PA); Hybrid; USD 177,000 - 294,000; Full time

Job summary

Pfizer seeks a Director of Computer System Quality Lead to drive risk-based Computer System Assurance across Pfizer Global Site services and Digital teams. You will serve as the Quality authority for Digital processes, guiding complex risk classifications, assurance strategies, and compliance matters.

You will provide leadership for validation and ongoing management of GMP/GDP enterprise Digital and AI solutions, while supporting regulatory inspections and cross-functional initiatives.

Qualifications

• Bachelor’s degree in science/engineering/tech/data/quality with 8+ years experience; or Master’s with 7+; or PhD with 5+ years.
• Significant experience in computerized-system quality/CS Assurance in GMP/GDP or similar regulated environment.
• Proven leadership for quality processes, maintenance, and inspection support.

Responsibilities

• Define risk-based Computer System Assurance strategies across Pfizer sites and Digital orgs.
• Serve as Quality authority for Digital process framework across units.
• Provide decisions on complex enterprise-system risk assessments and assurance approaches.
• Oversee validation and ongoing management of GMP/GDP enterprise Digital/AI/federated solutions.
• Lead Level 2 CSP Assurance governance, adoption, improvements, metrics, and inspection support.
• Lead portfolio-level audits and inspection readiness; identify systemic risks and CAPAs.
• Represent quality in regulatory inspections, internal audits, governance forums.
• Monitor regulatory expectations and translate to practical quality controls.
• Identify opportunities to simplify assurance via AI, automation and Digital capabilities.

Skills

Quality assurance

Risk management

Regulatory inspections

Cross-functional leadership

Education

Bachelor's degree

Master's degree

Doctoral degree

Job description

Pfizer seeks a Director of Computer System Quality Lead to drive risk-based Computer System Assurance across Pfizer Global Site services and Digital teams. You will serve as the Quality authority for Digital processes, guiding complex risk classifications, assurance strategies, and compliance matters.

You will provide leadership for validation and ongoing management of GMP/GDP enterprise Digital and AI solutions, while supporting regulatory inspections and cross-functional initiatives.