Senior Quality Engineer - GMP Readiness Lead

Solomon Page; Sanford (NC); On-site; USD 90,000 - 96,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

401(k)

Direct deposit

Commuter benefits

Job summary

Solomon Page seeks a Senior Quality Engineering Consultant to lead GMP readiness at Kyowa Kirin's Sanford, NC site. You will provide quality governance for facilities, utilities, equipment, and documentation, ensuring inspection readiness and lifecycle management across asset systems.

You will drive risk assessments, change control, investigations, CAPAs, and continuous improvement while partnering with Engineering, Validation, Maintenance, and Manufacturing teams to sustain compliance during

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline required.
• Master's degree preferred.

Responsibilities

• Provide Quality Engineering leadership for Sanford site, supporting GMP readiness and compliance.
• Oversee qualification/validation activities for equipment, facilities, utilities, and systems.
• Lead risk assessments (FMEA, hazard analyses) and change control processes.

Skills

Quality Engineering

GxP compliance

Regulatory inspections

CAPA & Deviations

Change control

Data integrity

21 CFR Part 11

Education

Bachelor's degree in Engineering or Science

Master's degree preferred

Tools

CQV protocols

Job description

Solomon Page seeks a Senior Quality Engineering Consultant to lead GMP readiness at Kyowa Kirin's Sanford, NC site. You will provide quality governance for facilities, utilities, equipment, and documentation, ensuring inspection readiness and lifecycle management across asset systems.

You will drive risk assessments, change control, investigations, CAPAs, and continuous improvement while partnering with Engineering, Validation, Maintenance, and Manufacturing teams to sustain compliance during