Quality Excellence Leader – Data-Driven GMP & CI

Sanofi Group; Swiftwater (Monroe County); On-site; USD 113,000 - 164,000; Full time

Benefits offered by this job

Health benefits

Career growth opportunities

On-site work

Job summary

Sanofi in Swiftwater, PA is seeking a Quality Excellence Manager to lead the site’s quality improvement program and sustain SMS 2.0 practices. You will coach the quality excellence team, align metrics with global quality goals, and drive data‑driven decisions on product quality and process performance on the manufacturing floor.

You’ll collaborate with cross‑functional partners, implement CAPA programs, and ensure regulatory compliance across GMP frameworks.

Qualifications

• Bachelor's degree in science, engineering, or a related technical field.
• Master's degree preferred for advanced roles.
• 5+ years in Quality Assurance roles with strong GMP/pharma manufacturing exposure.

Responsibilities

• Promote a culture of excellence and ensure full implementation and sustainability of SMS 2.0.
• Identify and implement continuous improvement initiatives to enhance product quality and operational efficiency (SMS 2.0).
• Monitor and analyze quality performance data to identify trends and improvement areas.
• Support the investigational process of complex events to determine true root causes and relevant CAPAs.
• Develop a culture of continuous improvement within the site and lead quality performance metrics.

Skills

Quality Assurance

Operational Excellence

Data analysis

Leadership

Education

Bachelor's degree in science or engineering

Master's degree preferred

Tools

Excel

Power BI

Job description

Sanofi in Swiftwater, PA is seeking a Quality Excellence Manager to lead the site’s quality improvement program and sustain SMS 2.0 practices. You will coach the quality excellence team, align metrics with global quality goals, and drive data‑driven decisions on product quality and process performance on the manufacturing floor.

You’ll collaborate with cross‑functional partners, implement CAPA programs, and ensure regulatory compliance across GMP frameworks.