Senior Specialist, Quality Engineer
$116,000–$152,300 year
On-siteSanford, North Carolina, United States
Job Summary
Implement and sustain assigned Quality Engineering processes for the Sanford site startup and operation, providing technical oversight for facilities, utilities, equipment, and manufacturing processes. Own assigned activities including lifecycle management, change controls, deviations, CAPAs, and risk assessments such as FMEA and hazard analysis. Execute audit and inspection readiness actions by preparing documentation, participating in walkthroughs, and fulfilling regulatory commitments. Partner with Engineering, Validation, Maintenance, and Manufacturing stakeholders to maintain inspection-ready documentation and enable compliant execution of startup and operational activities. Report to the Sr. Manager, Quality Systems & Compliance, with up to 10% domestic and limited international travel. This on-site role in Sanford, NC, supports GMP operations and audit defense within Kyowa Kirin's global specialty pharmaceutical business.
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmaceutical Sciences or related field
- Minimum 5 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering
- Demonstrated experience serving as a Quality SME during regulatory inspections and/or audits
- Demonstrated experience in qualification, validation, change control, and Quality Engineering activities
- Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE
- This position is based on-site in Sanford, NC
- Other standard company policies for flexible work arrangements do not apply to this role
- This is not a hybrid or remote role
- Requires up to 10% domestic and limited international travel
Desired Qualifications
- Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms
- Familiarity with single-use DS biologics operations or greenfield startup environments
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