Senior Quality Engineer - GMP Startup Expert

Kyowa Kirin North America; Sanford (NC); On-site; USD 116,000 - 152,000; Full time

Benefits offered by this job

401K with company matching

Annual Bonus Program

PTO and holidays

Healthcare Benefits

Job summary

Kyowa Kirin North America, Sanford site, is seeking a Senior Specialist, Quality Engineer to support startup and ongoing operations. This on-site role provides hands-on quality oversight for facilities, utilities, equipment, and manufacturing processes within a GMP framework.

The incumbent will own Quality Engineering deliverables, drive risk-based decisions, and assist in inspection readiness while collaborating with cross-functional teams in a global organization.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences or related field.
• Minimum 5+ years in a GxP-regulated environment with focus on Quality Engineering.
• Experience as Quality SME during regulatory inspections and/or audits.

Responsibilities

• Provide Quality Engineering support for startup and operation at Sanford site.
• Review and approve GMP readiness activities for facilities, utilities, equipment, and processes.
• Manage lifecycle activities through change controls, deviations, CAPAs, and calibrations.
• Drive structured problem solving for equipment, utilities, and facilities.
• Prepare documentation for inspections and audits and maintain data integrity.

Skills

Quality Engineering

GxP compliance

Risk assessment

Change control

CAPA management

ALCOA+

Document control

Regulatory inspections

Education

Bachelor’s degree in Life Sciences/Pharmaceutical Sciences

Tools

PM systems

Calibration systems

CMMS platforms

Job description

Kyowa Kirin North America, Sanford site, is seeking a Senior Specialist, Quality Engineer to support startup and ongoing operations. This on-site role provides hands-on quality oversight for facilities, utilities, equipment, and manufacturing processes within a GMP framework.

The incumbent will own Quality Engineering deliverables, drive risk-based decisions, and assist in inspection readiness while collaborating with cross-functional teams in a global organization.