Head of Computer System Quality & Digital Assurance

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

Benefits offered by this job

401(k) matching

Retirement contribution

Paid vacation

Health benefits

Job summary

Pfizer in Collegeville, PA, seeks a Director of Computer System Quality to lead assurance for GMP/GDP computer systems across Pfizer sites and Digital teams. You will set risk-based strategies, supervise validations, and guide regulatory inspections with senior leadership.

You will partner with Quality, Digital, and portfolio teams to adopt AI, automation, and continuous monitoring, ensuring data integrity and patient safety throughout system lifecycles.

Qualifications

• Bachelor’s degree with 8+ years in computerized-system quality or QA.
• Experience in GMP/GDP regulated environments and computer-system validation.
• Proven leadership in cross-functional, global initiatives.

Responsibilities

• Define risk-based CS Assurance strategies for Pfizer sites and Digital orgs.
• Act as Quality authority for Digital process framework and provide recommendations on complex risk assessments.
• Lead audits, inspections readiness, and identify systemic risks with CAPA recommendations.
• Represent CS quality during regulatory inspections and internal audits.
• Mentor teams and align Quality with Digital, site and business stakeholders.
• Monitor evolving regulatory expectations and translate into practical controls.

Skills

CS Assurance

Risk-based QA

Regulatory inspections

Cross-functional leadership

AI in QA

Education

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

Master’s degree in relevant field

Doctoral degree in relevant field

Job description

Pfizer in Collegeville, PA, seeks a Director of Computer System Quality to lead assurance for GMP/GDP computer systems across Pfizer sites and Digital teams. You will set risk-based strategies, supervise validations, and guide regulatory inspections with senior leadership.

You will partner with Quality, Digital, and portfolio teams to adopt AI, automation, and continuous monitoring, ensuring data integrity and patient safety throughout system lifecycles.